title: Effects of continuous positive airway pressure on fatigue and sleepiness in patients with obstructive sleep apnea: data from a randomized controlled trial. Cognitive complaints after breast cancer treatments: examining the relationship with neuropsychological test performance. Assessment of Daily and Weekly Fatigue Among African American Cancer Survivors A randomized controlled trial of an internet intervention for adults with insomnia: effects on comorbid psychological and fatigue symptoms. Surviving cancer: a comparison of 5-year disease-free breast cancer survivors with healthy women. Light treatment prevents fatigue in women undergoing chemotherapy for breast cancer Randomized phase III clinical trial of five different arms of treatment for patients with cancer cachexia: interim results. A multi-nutrient supplement reduced markers of inflammation and improved physical performance in active individuals of middle to older age: a randomized, double-blind, placebo-controlled study Increased Affective Bias Revealed Using Experimental Graded Heat Stimuli in Young Depressed Adults: Evidence of “Emotional Allodynia” Phase II nonrandomized study of the efficacy and safety of COX-2 inhibitor celecoxib on patients with cancer cachexia Cancer-related anorexia/cachexia syndrome and oxidative stress: an innovative approach beyond current treatment. A pilot study exploring the effects of a 12-week t'ai chi intervention on somatic symptoms of depression in patients with heart failure. A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors. Pre-treatment symptom cluster in breast cancer patients is associated with worse sleep, fatigue and depression during chemotherapy. Randomized phase III clinical trial of five different arms of treatment in 332 patients with cancer cachexia. Initial evaluation of an Internet intervention to improve the sleep of cancer survivors with insomnia. Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2. Validation of a modified Rotterdam Symptom Checklist for use with cancer patients in the United States. The longitudinal relationship between fatigue and sleep in breast cancer patients undergoing chemotherapy. The relationship between fatigue and light exposure during chemotherapy A Phase II Study with Antioxidants, Both in the Diet and Supplemented, Pharmaconutritional Support, Progestagen, and Anti-Cyclooxygenase-2 Showing Efficacy and Safety in Patients with Cancer-Related Anorexia/Cachexia and Oxidative Stress
abstract: OBJECTIVES Complaints of fatigue are frequent in patients with obstructive sleep apnea ( OSA ) ; however , the impact of continuous positive airway pressure ( CPAP ) on fatigue remains unclear . METHODS Fifty-nine men and women with OSA were r and omly assigned to therapeutic or placebo CPAP in a double-blind fashion for a 3-week intervention period . Four outcome measures were assessed : ( 1 ) fatigue/vigor measured with the Multidimensional Fatigue Symptom Inventory -- Short Form ( MFSI-sf ) , the ( 2 ) fatigue and ( 3 ) vigor subscales of the Profile of Mood States -- Short Form ( POMS ) , and ( 4 ) the Epworth Sleepiness Scale ( ESS ) . Data were analyzed using repeated- measures analysis of variance . RESULTS Compared with patients receiving placebo CPAP , those patients treated with therapeutic CPAP showed significant reductions in the apnea-hypopnea index , as well as decreases in both measures of fatigue and increases in vigor ( P values < 0.05 ) . The beneficial effect of therapeutic treatment was most pronounced in patients with high levels of fatigue at study onset . Significant treatment effects in sleepiness scores were not observed in the entire sample ( P > 0.05 ) ; however , in a subset of patients with excessive sleepiness at the onset of treatment , ESS scores were significantly reduced with use of therapeutic CPAP ( P < 0.05 ) . CONCLUSIONS Results suggest that 3 weeks of therapeutic CPAP significantly reduced fatigue and increased energy in patients with OSA . Therapeutic CPAP significantly reduced daytime sleepiness in patients who reported excessive sleepiness at the onset of treatment BACKGROUND Cognitive complaints are reported frequently after breast cancer treatments . Their association with neuropsychological ( NP ) test performance is not well-established . METHODS Early-stage , posttreatment breast cancer patients were enrolled in a prospect i ve , longitudinal , cohort study prior to starting endocrine therapy . Evaluation included an NP test battery and self-report question naires assessing symptoms , including cognitive complaints . Multivariable regression models assessed associations among cognitive complaints , mood , treatment exposures , and NP test performance . RESULTS One hundred eighty-nine breast cancer patients , aged 21 - 65 years , completed the evaluation ; 23.3 % endorsed higher memory complaints and 19.0 % reported higher executive function complaints ( > 1 SD above the mean for healthy control sample ) . Regression modeling demonstrated a statistically significant association of higher memory complaints with combined chemotherapy and radiation treatments ( P = .01 ) , poorer NP verbal memory performance ( P = .02 ) , and higher depressive symptoms ( P < .001 ) , controlling for age and IQ . For executive functioning complaints , multivariable modeling controlling for age , IQ , and other confounds demonstrated statistically significant associations with better NP visual memory performance ( P = .03 ) and higher depressive symptoms ( P < .001 ) , whereas combined chemotherapy and radiation treatment ( P = .05 ) approached statistical significance . CONCLUSIONS About one in five post-adjuvant treatment breast cancer patients had elevated memory and /or executive function complaints that were statistically significantly associated with domain-specific NP test performances and depressive symptoms ; combined chemotherapy and radiation treatment was also statistically significantly associated with memory complaints . These results and other emerging studies suggest that subjective cognitive complaints in part reflect objective NP performance , although their etiology and biology appear to be multifactorial , motivating further transdisciplinary research This investigation evaluates two common measures of cancer-related fatigue , one multidimensional/retrospective and one unidimensional/same day . Fifty-two African American survivors of diverse cancers completed  fatigue visual analogue scales once daily , and the Multidimensional Fatigue Symptom Inventory-Short Form ( MFSI-SF ) once weekly , for four weeks . Zero-order correlations showed retrospective fatigue was significantly related to average , peak , and most recent same-day fatigue . Multilevel r and om coefficient modeling showed unidimensional fatigue shared the most variance with the MFSI-SF 's General subscale for three weeks , and with the Vigor subscale for one week . Research ers and clinicians may wish to prioritize multidimensional measures when assessing cancer-related fatigue , if appropriate OBJECTIVE Insomnia is frequently comorbid with other medical and psychological disorders . This secondary data analysis investigated whether an Internet-delivered cognitive behavioral therapy for insomnia ( CBT-I ) intervention could also reduce comorbid psychological and fatigue symptoms . METHOD Data from a pilot r and omized controlled trial ( RCT ) testing the efficacy of Internet-delivered CBT-I relative to a waitlist control was used to examine changes in symptoms of depression , anxiety , mental health quality of life ( QOL ) , and fatigue . RESULTS Group by time interactions from repeated measures analyses revealed significant post intervention improvements in Internet participants ( n = 22 ) relative to  control participants ( n = 22 ) on all psychological symptoms , mental health QOL , and fatigue . A small post hoc sub sample of Internet participants with mild or moderate depression also showed large effect size changes in these constructs ( depression , anxiety , mental health QOL , and fatigue ) . CONCLUSION Internet-delivered CBT-I appears to not only improve sleep but also reduce comorbid psychological and fatigue symptoms Women with breast cancer are one of the largest groups of cancer survivors . This research examined whether breast cancer has a long-term impact on quality of life ( QOL ) by comparing 5-year disease-free survivors to age-matched controls and by comparing women who sustained a recurrence to disease-free survivors . Controls  were recruited using the neighborhood control methodology .  QOL ( physical , emotional , social , and spiritual ) was assessed during in-person interviews . There were no differences between disease-free survivors ( n = 267 ) and controls ( n = 187 ) on many indicators of QOL . However , survivors reported more difficulties with physical functioning , more physical symptoms , and more faith than did controls ( all ps < 0.05 ) . Compared to disease-free survivors , survivors with a recurrence ( n = 37 ) had a worse QOL on most indices , less positive affect , more general fatigue , and more intrusive and avoidant thoughts ( all ps < 0.05 ) . There were no differences between the two groups of survivors on indices of marriage , work experiences , or spirituality . These findings suggest that the QOL of long-term survivors who remain disease-free is comparable to that of women their age with the exception of physical functioning . Women who sustain a recurrence suffer an impaired QOL in some , but not all , domains Purpose Fatigue is one of the most disturbing complaints of cancer patients and is often the reason for discontinuing treatment . This r and omized controlled study tested the hypothesis that increased morning bright light , compared to dim light , would result in less fatigue in women with breast cancer undergoing chemotherapy . Methods Thirty-nine women newly diagnosed with stage I – III breast cancer were r and omized to either  bright white light ( BWL ) or dim red light ( DRL ) treatment and were instructed to use the light box for 30 min every morning throughout the first four cycles of chemotherapy . The Multidimensional Fatigue Symptom Inventory was administered prior to the start of chemotherapy ( baseline ) , during the chemotherapy treatment week of cycle 1 ( C1TW ) , the last week ( recovery week ) of cycle 1 ( C1RW ) , the chemotherapy treatment week of cycle 4 ( C4TW ) , and the last week ( recovery week ) of cycle 4 ( C4RW ) . Results The DRL group reported increased fatigue at C1TW ( p = 0.003 ) and C4TW ( p < 0.001 ) compared to baseline , while there was no significant change from baseline in the BWL group . A secondary analysis showed that the increases in fatigue levels in the DRL group were not mediated through nor associated with changes in sleep or in circadian rhythms as measured with wrist actigraphy . Conclusions The results of this study suggest that morning bright light treatment may prevent overall fatigue from worsening during chemotherapy . Although our hypothesis that overall fatigue would improve with bright light treatment was not supported , the lack of deterioration in total fatigue scores suggests that bright morning light may be a useful intervention during chemotherapy for breast cancer OBJECTIVE In April 2005 a phase III r and omized study was started to establish which was the most effective and safest treatment of cancer-related anorexia/cachexia syndrome and oxidative stress in improving identified primary endpoints : increase of lean body mass , decrease of resting energy expenditure ( REE ) , increase of total daily physical activity , decrease of interleukin-6 and tumor necrosis factor-alpha , and improvement of fatigue assessed by the Multidimensional Fatigue Symptom Inventory-Short Form ( MFSI-SF ) . METHODS All patients were given as basic treatment polyphenols plus antioxidant agents alpha-lipoic acid , carbocysteine , and vitamins A , C , and E , all orally . Patients were then r and omized to one of the following five arms : 1 ) medroxyprogesterone acetate/megestrol acetate ; 2 ) pharmacologic nutritional support containing eicosapentaenoic acid ; 3 ) L-carnitine ; 4 ) thalidomide ; or 5 ) medroxyprogesterone acetate/megestrol acetate plus pharmacologic nutritional support plus L-carnitine plus thalidomide . Treatment duration was 4 mo . The sample comprised 475 patients . RESULTS By January 2007 , 125 patients , well balanced for all clinical characteristics , were included . No severe side effects were observed . As for efficacy , an interim analysis on 125 patients showed an improvement of at least one primary endpoint in arms 3 , 4 , and 5 , whereas arm 2 showed a significant worsening of lean body mass , REE , and MFSI-SF . Analysis of variance comparing the change of primary endpoints between arms showed a significant improvement of REE in favor of arm 5 versus arm 2 and a significant improvement of MFSI-SF in favor of arms 1 , 3 , and 5 versus arm 2 . A significant inferiority of arm 2 versus arms 3 , 4 , and 5 for the primary endpoints lean body mass , REE , and MFSI-SF was observed on the basis of t test for changes . CONCLUSION The interim results obtained thus far seem to suggest that the most effective treatment for cancer-related anorexia/cachexia syndrome and oxidative stress should be a combination regimen . The study is still in progress and the final results should confirm these data Background While exercise acts to combat inflammation and aging , the ability to exercise may itself be compromised by inflammation and inflammation 's impact on muscle recovery and joint inflammation . A number of nutritional supplements have been shown to reduce inflammation and improve recovery . The purpose of the current investigation was to examine the effect of a multi-nutrient supplement containing branched chain amino acids , taurine , anti-inflammatory plant extracts , and B vitamins on inflammatory status , endothelial function , physical function , and mood in middle-aged individuals . Methods Thirty-one healthy and active men ( N = 16 , mean age 56 ± 6.0 yrs ) and women ( N = 15 , mean age = 52 ± 7.5 yrs ) participated in this investigation . Subjects completed one 28 day cycle of placebo supplementation and one 28 day cycle of multi-nutrient supplementation ( separated by a one week washout period ) in a balanced , r and omized , double-blind , cross-over design . Subjects completed weekly perceptual logs ( PROMIS-57 , KOOS ) and pre- and post- testing around the supplementation period . Testing consisted of brachial artery flow mediated dilation ( FMD ) , blood measures , and physical performance on vertical jump , h and grip strength , and balance ( dispersion from center of pressure ) . Significance for the investigation was p ≤ 0.05 . Results IL-6 significantly decreased in both men ( from 1.2 ± 0.2 to 0.7 ± 0.4 pg·mL-1 ) and women ( from 1.16 ± 0.04 to 0.7 ± 0.4 pg·mL-1 ) . Perceived energy also improved for both men ( placebo : 1.8 ± 0.7 ; supplement : 3.7 ± 0.8 AUC ) and women ( placebo : 1.2 ± 0.7 ; supplement : 2.8 ± 0.8 AUC ) . Alpha-1-antichymotrypsin ( from 108.9 ± 38.6 to 55.5 ± 22.2 ug·mL-1 ) , Creatine Kinase ( from 96 ± 34 to 67 ± 23 IU·L-1 ) , general pain , and joint pain decreased in men only , while anxiety and balance ( from 0.52 ± 0.13 to 0.45 ± 0.12 cm ) improved in women only . Men showed increased performance in vertical jump power ( from 2642 ± 244 to 3134 ± 282 W ) and grip strength ( from 42.1 ± 5.9 to 48.5 ± 4.9 kg ) . Conclusions A multi-nutrient supplement is effective in improving inflammatory status in both men and women , markers of pain , joint pain , strength , and power in men only , and both anxiety and balance ( a risk factor for hip fracture ) in women . Therefore , a multi-nutrient supplement may help middle-aged individuals to prolong physical function and maintain a healthy , active lifestyle Objective : To examine the hypothesis that young adults with major depressive disorder ( MDD ) would show increased affective bias to painful and nonpainful experimental heat stimuli , as evidence d by an increased responsiveness to warm and hot temperatures . Pain and depression often occur together . Pain is both a sensation and an affective experience . Similarly , depression is associated frequently with somatic symptoms as well as emotional dysphoria . Existing evidence indicates that MDD may be associated with altered pain processing . However , the extent to which alterations in experimentally controlled heat pain sensations are related to increased affective bias in MDD is unknown . Method : Grade d nonnoxious and noxious heat stimuli were delivered r and omly with a thermode applied to the volar surface of the left arm of 15 unmedicated subjects with current MDD and 15 age- and gender-matched healthy comparison subjects . MDD and non-MDD subjects rated the intensity and unpleasantness of all stimuli . Results : Two main results were observed . First , MDD relative to non-MDD subjects showed decreased heat pain thresholds . Second , a significantly increased affective bias ( unpleasantness/intensity ) was observed in subjects with MDD , particularly over the range of nonnoxious heat stimuli . This bias was independent of the change in sensory pain thresholds . Conclusion : These findings represent corroborative evidence of abnormal affective heat pain processing in young adults with MDD , and suggest that MDD is associated with “ emotional allodynia , ” a qualitatively altered negative emotional response to normally nonaversive thermal stimuli . MDD = major depressive disorder Chronic inflammation is one of the main features of cancer cachexia . Experimental and clinical studies showed that cyclooxygenase-2 inhibitors , such as celecoxib , may be beneficial in counteracting major symptoms of this devastating syndrome . We carried out a prospect i ve phase II clinical trial to test the safety and effectiveness of an intervention with the COX-2 inhibitor celecoxib ( 300 mg/day for 4 months ) on key variables of cachexia ( lean body mass , resting energy expenditure , serum levels of proinflammatory cytokines , and fatigue ) in patients with advanced cancer at different sites . A sample of 24 patients was enrolled from January to December 2008 and all were deemed assessable . A significant increase of lean body mass and a significant decrease of TNF-α were observed . Moreover , an improvement of grip strength , quality of life , performance status , and Glasgow prognostic score was shown . There were no grade 3/4 toxicities . Patient compliance was very good ; no patient had to reduce the celecoxib dosage nor interrupt treatment . Our results showed that the COX-2 selective inhibitor celecoxib is an effective single agent for the treatment of cancer cachexia . Although the treatment of cancer cachexia , a multifactorial syndrome , is more likely to yield success with a multitargeted approach ; in the present study , we were able to show that a treatment , such as celecoxib , addressing a single target , albeit very important as chronic inflammation , could have positive effects . Therefore , phase III clinical trials are warranted to test the efficacy and safety of celecoxib OBJECTIVE Cancer-related anorexia/cachexia syndrome and oxidative stress play a key role in the progression and outcome of neoplastic disease . PATIENTS AND METHODS On the basis of our previously published studies and clinical experience , we have developed an innovative approach consisting of diet with high polyphenol content ( 400 mg ) , p.o . pharmaconutritional support enriched with n - 3 fatty acids ( eicosapentaenoic acid and docosahexaenoic acid ) 2 cans ( 237 mL each ) per day , medroxiprogesterone acetate 500 mg/d , antioxidant treatment with alpha-lipoic acid 300 mg/d plus carbocysteine lysine salt 2.7 g/d plus vitamin E 400 mg/d plus vitamin A 30,000 IU/d plus vitamin C 500 mg/d , and selective cyclooxygenase-2 inhibitor Celecoxib 200 mg/d . The treatment is administered for 16 weeks . The following variables are evaluated : ( a ) clinical variables ( stage and Eastern Cooperative Oncology Group performance status ) ; ( b ) nutritional variables ( lean body mass , appetite , and resting energy expenditure ) ; ( c ) laboratory variables ( serum levels of proinflammatory cytokines , C-reactive protein , and leptin and blood levels of reactive oxygen species and antioxidant enzymes ) ; and ( d ) quality of life variables ( European Organization for Research and Treatment of Cancer QLQ-C30 , EQ-5Dindex , and EQ-5DVAS ) . A phase II nonr and omized study has been design ed to enroll 40 patients with advanced cancer at different sites with symptoms of cancer-related anorexia/cachexia syndrome and oxidative stress . RESULTS As of January 2004 , 28 patients have been enrolled : 25 patients were evaluable and 14 of them have completed the treatment ( 20 patients have completed 2 months of treatment ) . As for clinical response , five patients improved , three patients remained unchanged , and six patients worsened . The Eastern Cooperative Oncology Group performance status ( grade ) 1 remained unchanged . As for nutritional/functional variables , the lean body mass increased significantly at 2 and 4 months . As for laboratory variables , reactive oxygen species decreased significantly and proinflammatory cytokines interleukin-6 and tumor necrosis factor-alpha decreased significantly . As for quality of life , it comprehensively improved after treatment . CONCLUSIONS The treatment has been shown to be effective for clinical response , increase of lean body mass , decrease of reactive oxygen species and proinflammatory cytokines , and improvement of quality of life . The treatment has been shown to be safe with good compliance of patients . The study is in progress ( 14 further patients will be included ) BACKGROUND Patients with chronic heart failure ( HF ) and with elevated depression symptoms are at greater risk of morbidity and mortality . Somatic symptoms of depression are particularly prevalent in HF and are related to worse disease prognosis . T'ai chi practice is related to increased emotional well-being in various clinical population s ; however , relatively little is known about t'ai chi 's effects on somatic versus cognitive symptom dimensions of depression in HF . PURPOSE The objective of the study was to measure whether a t'ai chi intervention effectively reduces somatic and /or cognitive symptoms of depression in patients with HF . METHODS Patients with HF were assigned to either t'ai chi training ( n=16 ) or a usual-care group ( n=12 ) . At baseline and after the 12-week intervention period , participants were evaluated for changes in depressive symptoms using Beck Depression Inventory ( BDI ) total scores ( BDI-t ) and subcategorized scores of BDI-somatic ( BDI-s ) and BDI-cognitive ( BDI-c ) , and for symptoms of fatigue using the Multidimensional Fatigue Symptom Inventory-Short Form . RESULTS Patients with HF in the t'ai chi group compared to the  usual-care  group had reduced BDI-s ( p≤0.017 ) , but not BDI-c ( p=0.50 ) scores from pre- to postintervention . Although t'ai chi did not significantly reduce fatigue , changes in physical fatigue ( p≤0.05 ) were independently associated with changes in BDI-t scores . CONCLUSIONS T'ai chi practice  reduced somatic symptoms of depression , which have been linked to worse prognosis in HF . Reductions in fatigue appear to explain some but not all of the reductions in somatic symptoms of depression OBJECTIVE To determine the feasibility and efficacy of a physical activity behavioural change intervention in managing cancer-related fatigue among gynaecological cancer survivors during and post anti-cancer treatments . METHODS A two arm , single blind , r and omised controlled trial was conducted within the Northern Irel and regional Cancer Centre . Thirty three sedentary gynaecological cancer survivors ( stage I-III ; ≤3 years post diagnosis ) , experiencing cancer-related fatigue ( mild-severe ) took part . Participants were r and omly assigned to a behavioural change , moderate intensity physical activity intervention ( n=16 ) or a Contact Control group ( n=17 ) . The primary outcome was fatigue ( Multidimensional Fatigue Symptom Inventory-Short Form and Functional Assessment in Chronic Illness Therapy-Fatigue subscale ) . Secondary outcomes included quality of life , physical functioning , positive and negative affect , depression , body composition , sleep dysfunction and self-reported physical activity . Feasibility was assessed based on the recruitment rate , programme and physical activity adherence and participants ' programme evaluation , including optional focus groups ( n=16 ) . RESULTS Twenty five percent of eligible women took part ( 33/134 ) . Participants were 8.7 ( SD=9.1 ) months post diagnosis , with a mean age of 53 ( SD=10.3 ) years . The majority of the sample had a diagnosis of ovarian ( n=12 ) or endometrial cancer ( n=11 ) . Significant differences favouring the intervention group were observed for fatigue at 12 weeks and 6 months follow-up ( 12 week : mean difference=-11.06 ; 95 % confidence interval (CI)=-21.89 to -0.23 ; effect size (d)=0.13 ; p=0.046 ; 6 month : mean difference=-19.48 ; 95 % CI=-19.67 to -19.15 ; effect size (d)=0.20 ; p=0.01 ) . A mean of 10 calls ( SD=1.2 calls ) were delivered to the Physical Activity Group , and 10 ( SD=1.6 calls ) to the CC group . The intervention was positively perceived based on exit question naire and focus group findings . CONCLUSIONS A physical activity behavioural change intervention for gynaecological cancer survivors is feasible in terms of participants ' programme adherence and evaluation , and the intervention demonstrates improvements in fatigue . However , confirmation in the form of a larger fully powered RCT is warranted OBJECTIVE The concept of symptom clusters is relatively new in cancer patients ' symptom management . This study , which spanned four cycles of chemotherapy , combined three commonly seen pre-treatment symptoms in cancer patients ( i.e. sleep disturbances , fatigue and depression ) into one symptom cluster , to explore the associations between pre-treatment cluster categories and longitudinal profiles of these same symptoms during chemotherapy . METHODS This was a prospect i ve study . Seventy-six women with newly diagnosed stage I-III breast cancer , scheduled to receive at least four cycles of adjuvant or neoadjuvant anthracycline-based chemotherapy participated . Data were collected at seven time points before and during treatment . Sleep quality was measured with the  Pittsburgh Sleep Quality Index  . Fatigue was measured with the Multidimensional Fatigue Symptom Inventory -- Short Form . Depressive symptoms were measured with the Center of Epidemiological Studies --Depression . Patients were divided into three groups based on the number of symptoms they experienced before the start of chemotherapy ( i.e. no symptoms , 1 - 2 symptoms or all three symptoms ) and a symptom cluster index ( SCI ) was computed . RESULTS All women reported worse sleep , more fatigue and more depressive symptoms during treatment compared with baseline ( all p's<0.01 ) ; however , those women with a higher SCI ( i.e. more symptoms pre-treatment ) continued to experience worse symptoms during treatment compared with those who began with fewer symptoms ( all p's<0.01 ) . CONCLUSIONS A higher clinical ly relevant-based pre-treatment symptom cluster was associated with more sleep disturbances , greater fatigue and more depressive symptoms during chemotherapy . Specific interventions for these pre-treatment symptoms may improve the frequency and severity of these same symptoms during chemotherapy , when they are most severe and most disruptive to quality of life PURPOSE A phase III , r and omized study was carried out to establish the most effective and safest treatment to improve the primary endpoints of cancer cachexia-lean body mass ( LBM ) , resting energy expenditure ( REE ) , and fatigue- and relevant secondary endpoints : appetite , quality of life , grip strength , Glasgow Prognostic Score ( GPS ) and proinflammatory cytokines . PATIENTS AND METHODS Three hundred thirty-two assessable patients with cancer-related anorexia/cachexia syndrome were r and omly assigned to one of five treatment arms : arm 1 , medroxyprogesterone ( 500 mg/day ) or megestrol acetate ( 320 mg/day ) ; arm 2 , oral supplementation with eicosapentaenoic acid ; arm 3 , L-carnitine ( 4 g/day ) ; arm 4 , thalidomide ( 200 mg/day ) ; and arm 5 , a combination of the above . Treatment duration was 4 months . RESULTS Analysis of variance showed a significant difference between treatment arms . A post hoc analysis showed the superiority of arm 5 over the others for all primary endpoints . An analysis of changes from baseline showed that LBM ( by dual-energy X-ray absorptiometry and by L3 computed tomography ) significantly increased in arm 5 . REE decreased significantly and fatigue improved significantly in arm 5 . Appetite increased significantly in arm 5 ; interleukin (IL)-6 decreased significantly in arm 5 and arm 4 ; GPS and Eastern Cooperative Oncology Group performance status ( ECOG PS ) score decreased significantly in arm 5 , arm 4 , and arm 3 . Toxicity was quite negligible , and was comparable between arms . CONCLUSION The most effective treatment in terms of all three primary efficacy endpoints and the secondary endpoints appetite , IL-6 , GPS , and ECOG PS score was the combination regimen that included all selected agents OBJECTIVE Insomnia is a common complaint among cancer survivors . Fortunately , cognitive-behavioral therapy for insomnia ( CBT-I ) has been shown to be an effective treatment in this population . However , it is rarely implemented given its limited availability . To address this barrier , we examined the ability of an easily accessible online CBT-I program to improve insomnia symptoms in cancer survivors . METHODS Twenty-eight cancer survivors with insomnia were r and omly assigned to either an Internet insomnia intervention ( n = 14 ) or to a waitlist control group ( n = 14 ) . The online program , Sleep Healthy Using The Internet , delivers the primary components of CBT-I ( sleep restriction , stimulus control , cognitive restructuring , sleep hygiene , and relapse prevention ) . Pre- and post- assessment data were collected via online question naires and daily sleep diaries . RESULTS Participants in the Internet group showed significant improvements at post- assessment compared with those in the control group in overall insomnia severity ( F(1,26 ) = 22.8 ; p<0.001 ) , sleep efficiency ( F(1,24 ) = 11.45 ; P = 0.002 ) , sleep onset latency ( F(1,24 ) = 5.18 ; P = 0.03 ) , soundness of sleep ( F(1,24 ) = 9.34 ; P = 0.005 ) , restored feeling upon awakening ( F(1,24 ) = 11.95 ; P = 0.002 ) , and general fatigue ( F(1,26 ) = 13.88 ; P = 0.001 ) . Although other group × time interactions were not significant , overall adjusted effect sizes for all sleep variables as well as for fatigue , depression , anxiety , and quality of life ranged from small to large . CONCLUSIONS CBT-I delivered through an interactive , individually tailored Internet intervention may be a viable treatment option for cancer survivors experiencing insomnia BACKGROUND Safe , effective interventions to improve cancer-related fatigue ( CRF ) are needed because it remains a prevalent , distressing , and activity-limiting symptom . Based on pilot data , a phase III trial was developed to evaluate the efficacy of American ginseng on CRF . METHODS A multisite , double-blind trial r and omized fatigued cancer survivors to 2000 mg of American ginseng vs a placebo for 8 weeks . The primary endpoint was the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form ( MFSI-SF ) at 4 weeks . Changes from baseline at 4 and 8 weeks were evaluated between arms by a two-sided , two- sample t test . Toxicities were evaluated by self-report and the National Cancer Institute 's Common Terminology Criteria for Adverse Events ( CTCAE ) provider grading . RESULTS Three hundred sixty-four participants were enrolled from 40 institutions . Changes from baseline in the general subscale of the MFSI-SF were 14.4 ( st and ard deviation [ SD ] = 27.1 ) in the ginseng arm vs 8.2 ( SD = 24.8 ) in the placebo arm at 4 weeks ( P = .07 ) . A statistically significant difference was seen at 8 weeks with a change score of 20 ( SD = 27 ) for the ginseng group and 10.3 ( SD = 26.1 ) for the placebo group ( P = .003 ) . Greater benefit was reported in patients receiving active cancer treatment vs those who had completed treatment . Toxicities per self-report and CTCAE grading did not differ statistically significantly between arms . CONCLUSIONS Data support the benefit of American ginseng , 2000 mg daily , on CRF over an 8-week period . There were no discernible toxicities associated with the treatment . Studies to increase knowledge to guide the role of ginseng to improve CRF are needed The Rotterdam Symptom Checklist ( RSCL ) is a well-known instrument for the assessment of symptom-related distress among cancer patients . Despite its broad application , the utility of the RSCL with patients of some cancers is hindered by the omission of several important physical symptoms and method ological limitations of previous validation studies . The aims of the present study were to modify the RSCL through the addition of several physical symptoms and to subsequently vali date the modified version of the Rotterdam Symptom Checklist ( RSCL-M ) with a heterogeneous sample of cancer patients from the United States . A total of 1,005 male and female cancer patients from two midwestern states completed the RSCL-M and several other self-report instruments . Results indicated that the RSCL-M is a reliable and valid instrument for use with cancer patients in the United States and is sensitive to differences in physical distress across groups expected to have distinct symptom-related distress profiles STUDY OBJECTIVE Fatigue and sleep disturbances are two of the most common and distressing symptoms of cancer patients . A relationship between the two symptoms was reported in symptom cluster studies ; however , only subjective measurements of sleep were examined and most studies were cross-sectional . In this study of women with breast cancer undergoing chemotherapy  , we explored the longitudinal relationship between fatigue and sleep measured both subjectively and objective ly . DESIGN Prospect i ve study . Data were collected at 7 time points : before ( baseline ) and during the 3 weeks of cycle 1 and cycle 4 chemotherapy . PARTICIPANTS Ninety-seven women with newly diagnosed stage I-III breast cancer who were scheduled to receive at least four 3-week cycles of chemotherapy .  MEASUREMENT AND RESULTS Objective sleep parameters were measured with an Actillume actigraph ( Ambulatory Monitoring Inc. ) . Subjective sleep quality was assessed with the Pittsburgh Sleep Quality Index ( PSQI ) . Fatigue was assessed with the Multidimensional Fatigue Symptom Inventory-Short Form ( MFSI-SF ) . Fatigue became worse during both cycles of chemotherapy ( P-values < 0.01 ) . Subjective sleep quality was poor at baseline and remained unchanged throughout treatment . Objective nighttime and daytime total sleep time increased compared to baseline during the treatment administration week of both cycles ; daytime total wake time decreased during the treatment week of both cycles and during the last 2 week of cycle 4 . Mixed model results revealed that fatigue was positively associated with total PSQI scores and with objective measures of total nap time , and negatively associated with total wake time during the day ( all P-values < 0.01 ) . CONCLUSION Fatigue was significantly associated with subjective reports of poor sleep and objective measures of daytime sleepiness , but not with nocturnal sleep as measured with actigraphy . This relationship between fatigue and sleep warrants further studies to explore their possible common underlying etiology Background Fatigue is one of the most common and distressing complaints among cancer patients , not only during radiation and chemotherapy , but also for months to years after the completion of treatment . Fatigue interferes with patients ’ daily lives , reduces their quality of life , and is often a significant reason why patients discontinue treatment . We hypothesized that some of the fatigue may be related to disrupted circadian rhythms and low light exposure . The main objective of this study therefore was to investigate the association between fatigue and light exposure among patients with breast cancer . Methods As part of a larger , ongoing prospect i ve study on fatigue , sleep , and circadian rhythms in patients with breast cancer , an analysis of 63 women newly diagnosed with stage I – IIIA breast cancer and scheduled to receive four cycles of adjuvant or neoadjuvant anthracycline-based chemotherapy  was conducted . Data were collected before and during weeks 1 , 2 , and 3 of cycle 1 and cycle 4 . Fatigue was assessed using the Short Form of Multidimensional Fatigue Symptom Inventory . Light exposure was recorded with a wrist actigraph . Results There were significant correlations between fatigue levels and light exposure ( r=−0.28 to −0.45 ) within both cycle 1 and cycle 4 , such that higher levels of fatigue were associated with less light exposure . There were also significant correlations between changes in light exposure and changes in fatigue within the first 2 weeks of each cycle ( r=−0.28 to −0.52 ) . Conclusions Increased fatigue was significantly correlated with decreased light exposure among patients with breast cancer . Although the cause and effect of exacerbated fatigue and decreased light exposure can not be confirmed by the current study , and lower light exposure may just in part be due to the fatigued patients spending less time outdoors in bright light , two hypotheses are proposed about the mechanisms by which light may alleviate the fatigue of patients with breast cancer . These results suggest the need for prospect i ve intervention studies of light therapy for breast-cancer-related fatigue Purpose : To test the efficacy and safety of an integrated treatment based on a pharmaconutritional support , antioxidants , and drugs , all given orally , in a population of advanced cancer patients with cancer-related anorexia/cachexia and oxidative stress . Patients and Methods : An open early-phase II study was design ed according to the Simon two-stage design . The integrated treatment consisted of diet with high polyphenols content ( 400 mg ) , antioxidant treatment ( 300 mg/d α-lipoic acid + 2.7 g/d carbocysteine lysine salt + 400 mg/d vitamin E + 30,000 IU/d vitamin A + 500 mg/d vitamin C ) , and pharmaconutritional support enriched with 2 cans per day (n-3)-PUFA ( eicosapentaenoic acid and docosahexaenoic acid ) , 500 mg/d medroxyprogesterone acetate , and 200 mg/d selective cyclooxygenase-2 inhibitor celecoxib . The treatment duration was 4 months . The following variables were evaluated : ( a ) clinical ( Eastern Cooperative Oncology Group performance status ) ; ( b ) nutritional [ lean body mass ( LBM ) , appetite , and resting energy expenditure ] ; ( c ) laboratory [ proinflammatory cytokines and leptin , reactive oxygen species ( ROS ) and antioxidant enzymes ] ; ( d ) quality of life ( European Organization for Research and Treatment of Cancer QLQ-C30 , Euro QL-5D , and MFSI-SF ) . Results : From July 2002 to January 2005 , 44 patients were enrolled . Of these , 39 completed the treatment and were assessable . Body weight increased significantly from baseline as did LBM and appetite . There was an important decrease of proinflammatory cytokines interleukin-6 ( IL-6 ) and tumor necrosis factor-α , and a negative relationship worthy of note was only found between LBM and IL-6 changes . As for quality of life evaluation , there was a marked improvement in the European Organization for Research and Treatment of Cancer QLQ-C30 , Euro QL-5DVAS , and multidimensional fatigue symptom inventory-short form scores . At the end of the study , 22 of the 39 patients were “ responders ” or “ high responders . ” The minimum required was 21 ; therefore , the treatment was effective and more importantly was shown to be safe . Conclusion : The efficacy and safety of the treatment have been shown by the study ; therefore , a r and omized phase III study is warranted . ( Cancer Epidemiol Biomarkers Prev 2006;15(5):1030–4
target: The MFSI-SF demonstrated moderate test-retest reliability in a small number of studies .
  The MFSI-SF fatigue subscales were positively correlated with measures of distress , depressive , and anxious symptoms .
background: Purpose Fatigue is a subjective complaint that is believed to be multifactorial in its etiology and multidimensional in its expression .
  Fatigue may be experienced by individuals in different dimensions as physical , mental , and emotional tiredness .
  The purpose s of this study were to review and characterize the use of the 30-item Multidimensional Fatigue Symptom Inventory-Short Form ( MFSI-SF ) in published studies and to evaluate the available evidence for its psychometric properties .