title: Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Neovastat (AE-941) in refractory renal cell carcinoma patients: report of a phase II trial with two dose levels. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473) Zinc Gluconate in the Treatment of Dysgeusia—a Randomized Clinical Trial Symptom profile of nasopharyngeal cancer patients during radiation therapy. Prospective phase II trial of concomitant boost radiotherapy for stage II nasopharyngeal carcinoma: an evaluation of response and toxicity. Qualitative and quantitative assessment of taste and smell changes in patients undergoing chemotherapy for breast cancer or gynecologic malignancies. Impact of nutrition on outcome: a prospective randomized controlled trial in patients with head and neck cancer undergoing radiotherapy. Neoadjuvant Docetaxel before Radical Prostatectomy in Patients with High-Risk Localized Prostate Cancer Effects of amifostine on acute toxicity from concurrent chemotherapy and radiotherapy for inoperable non-small-cell lung cancer: report of a randomized comparative trial. Radiochemotherapy with amifostine cytoprotection for head and neck cancer The effect of education in managing side effects in women receiving chemotherapy for treatment of breast cancer. High-dose sequential chemotherapy with recombinant granulocyte colony-stimulating factor and repeated stem-cell support for inflammatory breast cancer patients: does impact on quality of life jeopardize feasibility and acceptability of treatment? Induction Paclitaxel, Carboplatin, and Infusional 5‐FU Followed by Concurrent Radiation Therapy and Weekly Paclitaxel/Carboplatin in the Treatment of Locally Advanced Head and Neck Cancer: A Phase II Trial of the Minnie Pearl Cancer Research Network Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4). Confocal microscopy of the peripheral gustatory system: comparison between healthy subjects and patients suffering from taste disorders during radiochemotherapy. Late toxicity results of the GORTEC 94-01 randomized trial comparing radiotherapy with concomitant radiochemotherapy for advanced-stage oropharynx carcinoma: comparison of LENT/SOMA, RTOG/EORTC, and NCI-CTC scoring systems.
abstract: BACKGROUND The aim of the study was to analyse the toxicity and health related quality of life ( HRQoL ) of breast cancer patients treated with FAC ( 5-fluorouracil , doxorubicin , cyclophosphamide ) and TAC ( docetaxel , doxorubicin , cyclophosphamide ) with and without primary prophylactic G-CSF ( PPG ) .  PATIENTS AND METHODS This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients . After the entry of the first 237 patients , the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia . A total of 1047 evaluable patients from 49 centres in Spain , two in Pol and and four in Germany were included in the trial .  Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 question naires were compared in the three groups ( FAC , TAC pre-amendment and TAC post-amendment ) . RESULTS The addition of PPG to TAC significantly reduced the incidence of neutropenic fever , grade 2 - 4 anaemia , asthenia , anorexia , nail disorders , stomatitis , myalgia and dysgeusia . Patient QoL decreased during chemotherapy , more with TAC than FAC , but returned to baseline values afterwards . The addition of PPG to TAC significantly reduced the percentage of patients with clinical ly relevant Global Health Status deterioration ( 10 or more points over baseline value ) at the end of chemotherapy ( 64 % versus 46 % , P<0.03 ) . CONCLUSIONS The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects . The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG , particularly in the final part of chemotherapy treatment BACKGROUND renal cell carcinoma ( RCC ) is a potential target for anti-angiogenic drugs because of its high vascularization . Neovastat ( AE-941 ) is an inhibitor of angiogenesis with a mechanism of action that could prove beneficial in the treatment of RCC . Patients and design A phase II trial was conducted to identify the long-term safety profile of Neovastat in advanced cancer patients and to obtain preliminary information on its efficacy in solid tumors refractory to st and ard treatments . Neovastat ( 60 or 240 ml/day ) was administered orally ( b.i.d . ) to 144 patients with solid tumors refractory to st and ard therapies or for whom no st and ard treatments were available . RESULTS A survival analysis was conducted on 22 patients with a primary diagnosis of refractory RCC to determine whether the dose of Neovastat had any effect . A significant relationship between dose and survival was observed ; the median survival time was significantly longer ( 16.3 versus 7.1 months ; P = 0.01 ) in patients treated with Neovastat 240 ml/day ( n = 14 ) compared with patients receiving 60 ml/day ( n = 8) . No dose-limiting toxicity was reported . The most frequent adverse event was taste alteration ( 13.6 % ) . CONCLUSIONS Neovastat is well tolerated by advanced cancer patients at doses of 60 and 240 ml/day . The higher dose of Neovastat administered in this trial is associated with a survival benefit in RCC , which is not explained by differences in major prognostic factors AMD473 is a novel sterically hindered platinum cytotoxic with demonstrated ability to overcome acquired resistance to cisplatin in vitro and in human tumour xenografts . A single-agent dose escalating Phase I study was performed . AMD473 was initially administered intravenously as a 1 h infusion every 21 days to patients with advanced solid tumours . In total , 42 patients received a total of 147 cycles ( median 3 , range 1–8 ) of treatment at doses of 12 , 24 , 48 , 96 , 110 , 120 , 130 , and 150 mg m−2 . Dosing intervals of 21 and 28 days were explored at the recommended dose . Neutropenia and thrombocytopenia proved dose limiting . Other toxicities included moderate nausea , vomiting , anorexia , and a transient metallic taste . There was no significant alopecia . The maximum tolerated dose was 150 mg m−2 . Plasma pharmacokinetics were linear . Two patients with heavily pretreated ovarian cancer  showed partial response . Five patients ( mesothelioma , ovary , nonsmall cell lung , and melanoma )  showed prolonged stable disease  . AMD473 demonstrates encouraging activity in patients , including those with prior platinum exposure . Toxicity is predictable with linear pharmacokinetics , as was predicted by pre clinical studies . A dose of 120 mg m−2 every 21 days is recommended for Phase II evaluation although there is evidence that chemo-naive patients and those of good performance status may tolerate a higher dose In the treatment of dysgeusia , the use of zinc has been frequently tried , with equivocal results . The aim of the present r and omized clinical trial , which involved a sufficiently large sample , was therefore to determine the efficacy of zinc treatment . Fifty patients with idiopathic dysgeusia were carefully selected .  Zinc gluconate ( 140 mg/day ; n = 26 ) or placebo ( lactose ; n = 24 ) was r and omly assigned to the patients . The patients on zinc improved in terms of gustatory function ( p < 0.001 ) and rated the dysgeusia as being less severe ( p < 0.05 ) . Similarly , signs of depression in the zinc group were less severe ( Beck Depression Inventory , p < 0.05 ; mood scale , p < 0.05 ) . With the exception of the salivary calcium level , which was higher in the zinc patients ( p < 0.05 ) , no other significant group differences were found . In conclusion , zinc appears to improve general gustatory function and , consequently , general mood scores in dysgeusia patients PURPOSE This prospect i ve , longitudinal study was aim ed to describe the prevalence , severity , and pattern of symptoms over the course of radiation therapy in persons with nasopharyngeal carcinoma and to explore symptom severity by treatment modality . DESCRIPTION OF STUDY Thirty-seven patients completed this study , and 46 % received chemotherapy before radiation therapy .  A self-reported radiation symptom checklist and an objective mucositis assessment tool were used weekly to document oropharyngeal , skin , nose or ear , or more general side effects , and mucositis . RESULTS Oropharyngeal problems were the most severe complaints during radiation therapy . All patients experienced dry mouth , taste change , difficulty in swallowing , difficulty in opening their mouths , hoarseness , sore throat , and observable mucositis . Most reported moderate-to-severe dry mouth , difficulty in swallowing , and sore throat from weeks 3 through 7 . Skin problems were not prominent until week 4 . Patients also lost an average of 3.9 kg during the therapy . Sequential chemotherapy and radiation therapy was associated with more severe oropharyngeal problems than radiation therapy alone , but no significant differences in other problems were found . CLINICAL IMPLICATION S Despite recognition of the oropharyngeal side effects associated with irradiation , effective management protocol s for such symptoms have not been implemented in the studied institution . The frequency and intensity of the symptoms reported indicate an urgent need for increased vigilance about radiation-related side effects and pain management . As well , patient education about expected side effects may help mitigate the anxiety that patients experience when these symptoms occur INTRODUCTION Stage II nasopharyngeal carcinoma ( NPC ) treated with conventionally fractionated radiotherapy results in loco-regional control of around 80 % . This report aims to document the outcome of Stage II NPC patients treated with external beam radiotherapy delivered using an accelerated concomitant boost ( C-Boost ) schedule . METHODS AND MATERIAL S Twenty-five 1997 AJCC Stage II NPC patients were enrolled and analyzed in this preliminary report . The primary tumor and clinical ly involved nodes received a total dose of 72 Gy in 42 fractions . C-Boost for gross disease consisted of 18 Gy in 12 fractions commencing on day 19 and was delivered at least 6 hours after the first dose . Patients were assessed for response , survival , and toxicity . RESULTS With a median follow-up of 24 months , only one patient had pathologically confirmed local recurrence , necessitating IMRT . Two developed distant metastases for which they received chemotherapy . One died from systemic disease after refusing treatment for persistent neck lymphadenopathy . Two-year loco-regional control rates , overall survival and disease-free survival rates were 96 % , 96 % , and 88 % , respectively . All patients experienced some degree of acute and /or late toxicity . However , the toxicity profile was comparable to that seen following st and ard fractionation . Acute or late toxicities directly attributable to C-Boost were not observed . CONCLUSION This C-Boost radiotherapy regimen administers a substantially higher biologically effective dose compared with conventional radiation schedules . Preliminary locoregional control and survival rates are promising with no significant acute and /or late toxicities PURPOSE Smell and taste changes during chemotherapy are significant complaints of cancer patients . Loss of olfactory/gustatory function can lead to malnutrition , weight loss , and possibly a prolonged morbidity of chemotherapy-induced adverse effects , decreased quality of life , poor compliance , and even decreased therapy response . This prospect i ve study comprehensively investigated , to our knowledge for the first time , smell and taste changes in a cohort of 87 patients undergoing chemotherapy for breast cancer or gynecologic malignancies . PATIENTS AND METHODS Olfactory function was tested using Sniffin ' Sticks ( Burghart ; Wedel , Germany ) and gustatory function was tested using taste strips before , during , and immediately and 3 months after chemotherapy . RESULTS Olfactory and gustatory function significantly decreased during chemotherapy and recovered almost completely 3 months after chemotherapy .  Scores of odor thresholds were affected more than those of discrimination or identification . The olfactory function of older patients was affected more than that of younger patients . There was no difference in the olfactory function during chemotherapy with respect to the chemotherapeutic agent or initial diagnosis ( breast or ovarian cancer ) . Regarding taste , scores of salty taste were affected more than scores of sweet , sour , or bitter taste . The gustatory function did not differ significantly during chemotherapy with respect to age or diagnosis but did differ with respect to the chemotherapeutic agent . Taxane-based chemotherapy caused the most severe disorders . CONCLUSION Chemotherapy has a significant but transient effect on olfactory and gustatory function , possibly causing reduced appetite , a low energy intake , and weight loss . Additional spices and flavoring may compensate for this diminished chemosensory function , enhancing patient compliance and quality of life BACKGROUND We aim ed to determine the effect of dietary counseling or oral supplements on outcome for patients with cancer , specifically , nutritional outcome , morbidity , and quality of life ( QOL )  , during and 3 months after radiotherapy . METHODS Seventy-five patients with head and neck cancer who were referred for radiotherapy ( RT ) were r and omized to the following groups : group 1 ( n = 25 ) , patients who received dietary counseling with regular foods ; group 2 ( n = 25 ) , patients who maintained usual diet plus supplements ; and group 3 ( n = 25 ) , patients who maintained intake ad lib .  Nutritional intake ( determined by diet history ) and status ( determined by Ottery 's Subjective Global Assessment ) , and QOL ( determined by the European Organization for the Research and Treatment of Cancer Quality of Life Question naire version 3.0 [ EORTC QLQ-C30 ] ) were evaluated at baseline , at the end of RT , and at 3 months . RESULTS Energy intake after RT increased in both groups 1 and 2 ( p < or = .05 ) . Protein intake also increased in both groups 1 and 2 ( p < or = .006 ) . Both energy and protein intake decreased significantly in group 3 ( p < .01 ) . At 3 months , group 1 maintained intakes , whereas groups 2 and 3 returned to or below baseline levels . After RT , > 90 % of patients experienced RT toxicity ; this was not significantly different between groups , with a trend for reduced symptomatology in group 1 versus group 2/group 3 ( p < .07 ) . At 3 months , the reduction of incidence/severity of grade 1 + 2 anorexia , nausea/vomiting , xerostomia , and dysgeusia was different : 90 % of the patients improved in group 1 versus 67 % in group 2 versus 51 % in group 3 ( p < .0001 ) . After RT , QOL function scores improved ( p < .003 ) proportionally with improved nutritional intake and status in group 1/group 2 ( p < .05 ) and worsened in group 3 ( p < .05 ) ; at 3 months , patients in group 1 maintained or improved overall QOL , whereas patients in groups 2 and 3 maintained or worsened overall QOL . CONCLUSIONS During RT , nutritional interventions positively influenced outcomes , and counseling was of similar/higher benefit ; in the medium term , only counseling exerted a significant impact on patient outcomes Purpose : To determine the clinical , pathologic , and molecular effects of neoadjuvant docetaxel chemotherapy in high-risk localized prostate cancer . Experimental Design : Patients with biopsy Gleason scores of 8 to 10 , serum prostate-specific antigen levels > 20 ng/mL , and /or clinical stage T3 disease received weekly docetaxel ( 36 mg/m2 ) for 6 months , followed by radical prostatectomy , and were monitored with weekly visits , serum prostate-specific antigen measurements , and endorectal magnetic resonance imaging ( MRI ) . Frozen tumor specimens were collected for microarray analysis . Results : The 19 patients enrolled received 82 % of the planned chemotherapy .  Toxicity was mild to moderate ; fatigue and taste disturbance were common . Prostate-specific antigen declines of > 50 % were seen in 11 of 19 patients ( 58 % ; 95 % confidence interval , 33 - 80 % ) and endorectal MRI showed maximum tumor volume reduction of at least 25 % in 13 of 19 patients ( 68 % ; 95 % confidence interval , 47 - 85 % ) and at least 50 % in 4 patients ( 21 % ; 95 % confidence interval , 6 - 46 % ) . Sixteen patients completed chemotherapy and had radical prostatectomy ; none achieved pathologic complete response . Microarray analysis identified coordinate up-regulation of genes involved in and rogen metabolism associated with docetaxel therapy . Specifically , RNA expression for genes that decrease cellular levels of bioactive and rogens was coordinately increased in response to chemotherapy . Conclusions : Neoadjuvant docetaxel administered for 6 months before radical prostatectomy is feasible , well tolerated , and often results in prostate-specific antigen declines of > 50 % and decreased tumor volume on endorectal MRI . No pathologic complete responses were observed . Altered and rogen metabolism may partially account for the noted declines in prostate-specific antigen and be a mechanism for chemotherapy resistance PURPOSE To determine the ability of amifostine to reduce the severity and /or incidence of the acute toxicities of concurrent chemotherapy and radiotherapy ( RT ) for non-small-cell lung cancer . METHODS AND MATERIAL S Patients with inoperable , nonmetastatic non-small-cell lung cancer receiving concurrent chemoradiotherapy  were r and omized to one of two treatment groups . Arm 1 patients received thoracic RT ( total dose , 69.6 Gy in 58 fractions of 1.2 Gy b.i.d . 5 d/wk ) , plus oral etoposide ( 50 mg b.i.d . 30 min before thoracic RT for 10 days , repeated on Day 29 ) and cisplatin ( 50 mg/m2 i.v . on Days 1 , 8 , 29 , and 36 ) . Arm 2 patients received the same treatment plus amifostine ( 500 mg i.v . 20 - 30 min before any treatment the first 2 days of each week ) . Acute effects were assessed using the National Cancer Institute Common Toxicity Criteria . RESULTS Sixty-two patients were enrolled between November 1998 and January 2001 . The minimal follow-up was 24 months , and the median follow-up of living patients was 31 months . The patient and tumor characteristics were equally distributed between the patients in the two arms . The median survival time was 20 months in Arm 1 patients and 19 months in Arm 2 patients . The maximal esophageal toxicity was mild ( Grade 1 ) in 23 % , moderate ( Grade 2 ) in 42 % , and severe ( Grade 3 - 4 ) in 35 % of patients in Arm 1 ; the corresponding rates for the Arm 2 patients were 48 % , 35 % , and 16 % ( p = 0.021 ) . Severe pneumonitis occurred in 16 % of the Arm 1 and none of the Arm 2 patients ( p = 0.020 , chi-square test ) . Neutropenic fever occurred in 39 % of Arm 1 and 16 % of Arm 2 patients ( p = 0.046 , chi-square test ) . Mild hypotension , dysgeusia , and sneezing were significantly more frequent among the patients in Arm 2 . CONCLUSION Amifostine reduced the severity and incidence of acute esophageal , pulmonary , and hematologic toxicity result ing from concurrent cisplatin-based chemotherapy and RT . Amifostine had no apparent effect on survival in these patients with unresectable non-small-cell lung cancer , suggesting that it does not have a tumor-protective effect Abstract A r and omized study was conducted to evaluate the protective activity of amifostine ( A ) against the dose-limiting toxicities of radiochemotherapy ( RCT ) .  Patients with head and neck cancer received radiotherapy  ( 2 Gy/day 5 days a week up to 60 Gy ) with carboplatin 70 mg/m2 on days 1–5 and 21–25 inclusive . Patients either received RCT alone ( n=14 ) or RCT + A at a dose of 500 mg prior to treatment with carboplatin ( n=25 ) . There was a significant reduction in the incidence of grade 3/4 mucositis ( P<0.0001 ) , acute grade 2 xerostomia ( P<0.0001 ) and grade 3/4 thrombocytopenia ( P=0.012 ) in these patients who received A. The incidence of grade 2 late xerostomia at 12 months is 16.7 % and the incidence of loss of taste is 0 % in patients treated with A , as opposed to 54.5 % and 63.6 % in patients who received RCT alone . There were 18 ( 72 % ) complete responses ( CR ) and 6 ( 24 % ) partial responses ( PR ) in patients who received A , compared with 6 ( 43 % ) CR and 6 PR ( 43 % ) in patients treated with RCT alone . The disease-free survival at 12 months is 85.7 % in the RCT + A arm and 78.6 % in the RCT alone arm . The use of amifostine reduces the incidence and severity of acute and late toxicities associated with RCT whilst preserving antitumour activity PURPOSE / OBJECTIVES To determine the effectiveness of informational audiotapes on self-care behaviors , state anxiety , and use of self-care behaviors ; to describe the occurrence and intensity of common side effects in patients with breast cancer . DESIGN R and omized clinical trial . SETTING Outpatient chemotherapy clinics operated by a university center in a rural area . SAMPLE 70 women receiving their first treatment of chemotherapy .  METHODS Subjects completed demographic data and the Spielberger State-Trait Anxiety instrument ( stai ) . The experimental group received two audiotapes . At one and three months , subjects completed the modified nail self-care diary  and  stai via telephone . MAIN RESEARCH VARIABLES State anxiety , side-effect severity , and use and efficacy of self-care behaviors . FINDINGS The most frequent side effects were fatigue , nausea and vomiting , and taste change . The experimental group reported symptom improvements that were not found in the control group . The experimental group increased the use of recommended self-care behaviors , whereas the control group continued to use the same self-care behaviors without effectiveness . State anxiety for both groups diminished over time ; however , anxiety in the control group was consistently higher . CONCLUSIONS Audiotapes are effective teaching tools . Self-care behaviors can be taught and can be effective in managing side effects . Anxiety was high in both groups , but the symptom decreased in the women who received audiotapes and telephone calls . IMPLICATION S FOR NURSING Constraints on nurses decrease the length of teaching time available , but audiotapes provide effective teaching and reinforcement of education . Anxiety in clinical environments interferes with patient learning . Teaching effective self-care behaviors enhances patients ' independence , comfort , control , and quality of life PURPOSE This study was design ed to investigate the quality of life ( QOL ) of patients enrolled onto the High-Dose Chemotherapy for Breast Cancer Study Group trial ( PEGASE 02 ) , a French pilot multicenter trial of the treatment of inflammatory breast cancer ( IBC ) aim ed at evaluating ( 1 ) toxicity and feasibility of sequential high-dose chemotherapy ( HDC ) with recombinant human granulocyte colony-stimulating factor ( filgrastim ) and stem-cell support and ( 2 ) response to HDC in terms of pathologic response and survival . PATIENTS AND METHODS QOL measures were performed at inclusion and four times subsequently up to 1 year using an ad hoc side-effect question naire ( 19 physical symptoms ) and the European Organization for Research and Treatment of Cancer Quality -of-Life Question naire ( EORTC QLQ-C30 ) . RESULTS Of the 95 patients entered , the overall QOL question naire completion compliance was 75.6 % . During cycle 3 of HDC , the number of symptoms was high ( mean + /- SD QOL score , 10 + /- 3 ) , with fatigue , hair loss , appetite loss , nausea , change in taste , vomiting , fever , and weight loss reported by more than 60 % of patients . Toxicity and distress associated with HDC were reflected in the decline of four EORTC QLQ-C30 scores : global QOL ( P = .001 ) , and physical , role , and social functioning ( P < .001 for all statistics ) . However , QOL deterioration disappeared after treatment completion , except for physical functioning ( P = .025 ) . One year after inclusion , most QOL scores returned to baseline , and both emotional functioning and global QOL scores were even higher than baseline ( P = .030 and P = .009 , respectively ) . CONCLUSION If it is confirmed that improvements in pathologic response rates with HDC effectively translate into increased probabilities of survival for IBC patients , adoption of such treatment as PEGASE 02 will not involve crucial choices between length of life and QOL and should not be delayed for QOL arguments PURPOSE The purpose of this study was to evaluate the feasibility , toxicity , and efficacy of a novel combined-modality treatment for patients with locally advanced squamous carcinoma of the head and neck . PATIENTS AND METHODS In this multicenter , community-based phase II study , 123 previously untreated patients with locally advanced squamous carcinoma of the head and neck received 6 weeks of induction chemotherapy followed by concurrent high-dose radiation therapy and weekly chemotherapy . Induction chemotherapy included paclitaxel ( 200 mg/m2 , 1-hour i.v . infusion ) on days 1 and 22 , carboplatin ( AUC 6.0 i.v . ) on days 1 and 22 , and 5-fluorouracil ( 225 mg/m2 per day , 24-hour continuous i.v . infusion ) on days 1–43 . After 1 week without therapy , radiation therapy , 1.8 Gy/day , 5 days weekly , to a total dose of 68.4 Gy , was administered to the primary site and the bilateral cervical lymph nodes . During radiation therapy , patients also received six weekly doses of paclitaxel ( 50 mg/m2 , 1-hour i.v . infusion ) and carboplatin ( AUC 1.0 i.v ) . After completion of therapy , patients were restaged with computed tomographic and endoscopic examination ; patients in complete remission were followed up without further treatment . RESULTS One hundred twenty-three patients ( 74 % with stage IV disease ) entered this trial , and 111 patients ( 90 % ) completed the entire treatment course . Seventy of 116 evaluable patients ( 60 % ; 95 % CI , 51%-69 % ) had a clinical complete response to treatment . After a median follow-up of 24 months , the 2- and 3-year actuarial survivals were 66 % and 51 % , respectively . Local toxicity was moderately severe during combined-modality therapy ; however , xerostomia has been the only frequent chronic toxicity of this program . CONCLUSIONS This novel combined-modality treatment program , containing paclitaxel and avoiding the use of cisplatin , is feasible , is highly active , and can be administered with acceptable toxicity in a community-based setting . Aggressive nutritional support should be considered in patients receiving this regimen , to improve acute palliation and to maximize the delivery of combined-modality therapy . Further evaluation of this treatment program is warranted . Incorporation of various novel biologic agents , particularly the epidermal growth factor receptor antagonists , may further improve efficacy PURPOSE Taste alterations ( dysgeusia ) are well described in head and neck cancer patients who undergo radiotherapy ( RT ) . Anecdotal observations and pilot studies have suggested zinc may mitigate these symptoms . This multi-institutional , double-blind , placebo-controlled trial was conducted to provide definitive evidence of this mineral 's palliative efficacy . METHODS AND MATERIAL S A total of 169 evaluable patients were r and omly assigned to zinc sulfate 45 mg orally three times daily vs. placebo . Treatment was to be given throughout RT and for 1 month after . All patients were scheduled to receive > or = 2,000 cGy of external beam RT to > or = 30 % of the oral cavity , were able to take oral medication , and had no oral thrush at study entry .  Changes in taste were assessed using the previously vali date d Wickham question naire . RESULTS At baseline , the groups were comparable in age , gender , and planned radiation dose ( < 6,000 vs. > or = 6,000 cGy ) . Overall , 61 zinc-treated ( 73 % ) and 71 placebo-exposed ( 84 % ) patients described taste alterations during the first 2 months ( p = 0.16 ) . The median interval to taste alterations was 2.3 vs. 1.6 weeks in the zinc-treated and placebo-exposed patients , respectively ( p = 0.09 ) . The reported taste alterations included the absence of any taste ( 16 % ) , bitter taste ( 8 % ) , salty taste ( 5 % ) , sour taste ( 4 % ) , sweet taste ( 5 % ) , and the presence of a metallic taste ( 10 % ) , as well as other descriptions provided by a write in response ( 81 % ) . Zinc sulfate did not favorably affect the interval to taste recovery . CONCLUSION Zinc sulfate , as prescribed in this trial , did not prevent taste alterations in cancer patients who were undergoing RT to the oral pharynx OBJECTIVES Laser-scanning microscopy ( LSM ) was used to compare taste buds and epithelia of fungiform papillae of healthy subjects with those of patients suffering from taste disorders during/after radiochemotherapy ( RCT ) . Aim of the study was to investigate effects responsible for taste loss at a microscopic level . STUDY DESIGN Prospect i ve study . METHODS Data from 12 healthy subjects ( mean age 52.4 , SD 9.5 years ) were compared with those of 12 patients ( mean age 54.7 , SD 8.5 years ) with head and neck cancer suffering from taste disorders during RCT . Four parameters from LSM were selected for analysis : 1 ) distance between the pore of the taste buds of fungiform papillae and the crest of the papillary vessels ; 2 ) epithelial cells of each taste bud at 34 mum ; 3 ) , cell density , and 4 ) area of the taste pore at 4 mum . These data were correlated to measures of gustatory sensitivity obtained with both the vali date d " taste strips " test kit and electrogustometry . RESULTS Patients complaining from taste disorders during RCT exhibited a significant decrease of taste function assessed with both natural and electric stimuli . In these patients , we found thicker epithelia and smaller areas of the taste pores compared with healthy subjects . In 30 % of those patients , no taste pores were detectable ; in deeper sections , however , normal taste buds were present . CONCLUSIONS In conclusion , in RCT patients with taste disorders , LSM indicates changes of epithelia of fungiform papilla but no changes of the taste bud structure . Damage of the chorda tympani nerve by scattered rays , direct or indirect mucotoxic effects of chemotherapeutic agents , and covering of taste pores by epithelial cells are likely reasons for taste loss during RCT PURPOSE To prospect ively assess 5-year late toxicity in patients treated by concomitant radiochemotherapy for locally advanced oropharynx carcinoma using three different toxicity scales . METHODS AND MATERIAL S A total of 226 patients were entered in a Phase III multicenter , r and omized trial comparing radiotherapy alone ( 70 Gy in 35 fractions : Arm A ) with concomitant radiochemotherapy ( 70 Gy in 35 fractions with three cycles of a 4-day regimen containing carboplatin and 5-fluorouracil : Arm B ) . Five living patients , free of local or distant recurrences , could not be evaluated for late toxicity .  Forty-four patients were eligible for late toxicity with a median follow-up of 5 years .  Late toxicity was evaluated by the radiation oncologist using a large question naire containing 120 mixed items of three scales ( NCI-CTC , LENT/SOMA , and RTOG ) . The data were then transposed on separate scales using corresponding grade s. RESULTS The 5-year overall survival rate was 22 % in Arm B and 16 % in Arm A ( p = 0.05 ) . The 5-year locoregional control rate was 48 % in Arm B and 25 % in Arm A ( p = 0.002 ) . The spinal cord was not affected by the concomitant adjunct of chemotherapy , and no deaths were caused by late toxicity . Using the three late toxicity scales , 100 % of the patients treated with the combined modality ( Arm B ) developed one or more late complications vs. 94 % in the radiotherapy-alone arm ( Arm A ) . The difference was not statistically significant . The most commonly damaged organs ( all Grade 1 - 4 ) were the salivary gl and s ( 100 % in Arm B vs. 82 % in Arm A , p < 0.05 ) , skin ( 78 % vs. 47 % , p < 0.05 ) , teeth ( 67 % vs. 18 % , p < 0.05 ) , mucosa ( 59 % vs. 63 % p = not significant ) , and m and ible ( 44 % vs. 12 % , p < 0.05 ) . One or more Grade 3 - 4 complications occurred in 82 % of the patients in Arm B vs. 47 % in Arm A ( p = 0.02 ) but concerned only the teeth . The correlation between the RTOG and LENT/SOMA scale and between the NCI-CTC and LENT/SOMA scale were low for Grade 1 - 4 toxicity ( near 30 % ) . The transposability of a patient 's symptoms was significantly greater using the LENT/SOMA or RTOG/EORTC scaling systems than using the NCI-CTC system . CONCLUSION Concomitant radiochemotherapy increased overall survival and locoregional control rates . The difference between the two treatment groups for Grade 3 - 4 complications was only significant for the teeth . The late toxicity assessment of a treatment may depend on the toxicity scale used . The LENT/SOMA scale seems to be the most accurate scale , but most of the score results were not concordant with those obtained with other scales . The results of this study confirm the necessity of using a common late toxicity scale in clinical trials
target: Attempts to prevent dysgeusia through the prophylactic use of zinc sulfate or amifostine have been of limited benefit .
  Nutritional counseling may be helpful to some patients in minimizing the symptoms of dysgeusia .
  Conclusions Dysgeusia is a common oral side effect of cancer therapy ( radiotherapy , chemotherapy , or combined modality therapy ) and often impacts negatively on quality of life .
  From the current literature , there does not appear to be a predictable way of preventing or treating dysgeusia
background: Purpose The purpose was to review relevant scientific papers written since 1989 which focused on the prevalence and management of  dysgeusia as an oral side effect of cancer treatment .