## Protocol Section
### Identification Module
**NCT ID:** NCT02352779

**Brief Title:** Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors

**Official Title:** Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue

#### Organization Study ID Info
**ID:** URCC13091
#### Organization
**Class:** OTHER
**Full Name:** University of Rochester
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2014-01191
**Type:** REGISTRY
**Domain:** University of Rochester NCORP Research Base
**ID:** URCC13091
**Type:** OTHER
**Domain:** DCP
**ID:** URCC-13091
**Type:** OTHER
**Domain:** CTEP
**ID:** URCC-13091
**Type:** OTHER
**ID:** U10CA037420
**Link:** https://reporter.nih.gov/quickSearch/U10CA037420
**Type:** NIH
**ID:** UG1CA189961
**Link:** https://reporter.nih.gov/quickSearch/UG1CA189961
**Type:** NIH
**ID:** R03CA175599
**Link:** https://reporter.nih.gov/quickSearch/R03CA175599
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2016-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-08

**Type:** ACTUAL

**Last Update Submit Date:** 2017-07-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-08-08

**Type:** ACTUAL

**Results First Submit Date:** 2017-02-03

**Results First Submit QC Date:** 2017-07-05

#### Start Date
**Date:** 2015-02

**Status Verified Date:** 2017-07

#### Study First Post Date
**Date:** 2015-02-02
**Type:** ESTIMATED
**Study First Submit Date:** 2015-01-28
**Study First Submit QC Date:** 2015-01-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Gary Morrow

#### Responsible Party

**Investigator Affiliation:** University of Rochester NCORP Research Base

**Investigator Full Name:** Gary Morrow

**Investigator Title:** Principal Investigator, URCC NCORP Research Base

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This randomized pilot clinical trial studies omega-3 fatty acid in reducing cancer-related fatigue in breast cancer survivors. Supplementation with omega-3 fatty acid may help reduce cancer-related fatigue in breast cancer survivors.

**Detailed Description:** PRIMARY OBJECTIVE:

I. To collect preliminary statistical data (mean changes and standard deviations) on two omega-3 supplementation (omega-3 fatty acid) regimens (1.65 g/day and 3.3 g/day) compared to placebo for reducing cancer-related fatigue (CRF) in fatigued breast cancer survivors.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive low-dose omega-3 fatty acid supplementation orally (PO) twice daily (BID) and placebo PO BID for 6 weeks.

ARM II: Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.

ARM III: Patients receive placebo PO BID for 6 weeks.

### Conditions Module

**Conditions:**

- Breast Carcinoma

- Cancer

- Fatigue

**Keywords:**

- Cancer Survivor

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 108

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.

**Intervention Names:**

- Dietary Supplement: Omega-3 Fatty Acid

- Other: Placebo

- Other: Questionnaire Administration

- Other: Laboratory Biomarker Analysis

**Label:** Arm I (low-dose omega-3 fatty acid)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.

**Intervention Names:**

- Dietary Supplement: Omega-3 Fatty Acid

- Other: Questionnaire Administration

- Other: Laboratory Biomarker Analysis

**Label:** Arm II (high-dose omega-3 fatty acid)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Patients receive placebo PO BID for 6 weeks.

**Intervention Names:**

- Other: Placebo

- Other: Questionnaire Administration

- Other: Laboratory Biomarker Analysis

**Label:** Arm III (placebo)

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm I (low-dose omega-3 fatty acid)

- Arm II (high-dose omega-3 fatty acid)

**Description:** Given PO

**Name:** Omega-3 Fatty Acid

**Other Names:**

- O3FA

- Omega-3 Fatty Acids

- Omega-3 PUFA

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Arm I (low-dose omega-3 fatty acid)

- Arm III (placebo)

**Description:** Given PO

**Name:** Placebo

**Other Names:**

- PLCB

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Arm I (low-dose omega-3 fatty acid)

- Arm II (high-dose omega-3 fatty acid)

- Arm III (placebo)

**Description:** Ancillary studies

**Name:** Questionnaire Administration

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Arm I (low-dose omega-3 fatty acid)

- Arm II (high-dose omega-3 fatty acid)

- Arm III (placebo)

**Description:** Correlative studies

**Name:** Laboratory Biomarker Analysis

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine).

MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue).

**Measure:** Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value

**Time Frame:** Baseline to 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past
* Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer
* Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin)
* Must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine
* Be able to read English
* Able to swallow medication
* Give written informed consent

Exclusion Criteria:

* Have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as Lovaza®)
* Be taking anticoagulant medication (does not include aspirin)
* Have sensitivity or allergy to fish and/or shellfish
* Have sensitivity or allergy to soy and/or soybeans
* Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue

**Maximum Age:** 120 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Wichita

**Country:** United States

**Facility:** Wichita NCORP

**State:** Kansas

**Zip:** 67214

**Location 2:**

**City:** Grand Rapids

**Country:** United States

**Facility:** Cancer Research Consortium of West Michigan

**State:** Michigan

**Zip:** 49503

**Location 3:**

**City:** Rochester

**Country:** United States

**Facility:** University of Rochester NCORP Research Base

**State:** New York

**Zip:** 14642

**Location 4:**

**City:** Dayton

**Country:** United States

**Facility:** Dayton NCORP

**State:** Ohio

**Zip:** 45420

**Location 5:**

**City:** Greenville

**Country:** United States

**Facility:** Greenville Health System NCORP

**State:** South Carolina

**Zip:** 29605

**Location 6:**

**City:** Marshfield

**Country:** United States

**Facility:** Wisconsin NCORP

**State:** Wisconsin

**Zip:** 54449

#### Overall Officials

**Official 1:**

**Affiliation:** University of Rochester NCORP Research Base

**Name:** Luke Peppone

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Kleckner AS, Kleckner IR, Culakova E, Wojtovich AP, Klinedinst NJ, Kerns SL, Hardy SJ, Inglis JE, Padula GDA, Mustian KM, Janelsins MC, Dorsey SG, Saligan LN, Peppone LJ. Exploratory Analysis of Associations Between Whole Blood Mitochondrial Gene Expression and Cancer-Related Fatigue Among Breast Cancer Survivors. Nurs Res. 2022 Sep-Oct 01;71(5):411-417. doi: 10.1097/NNR.0000000000000598. Epub 2022 Apr 13.

**PMID:** 35416182

**Citation:** Inglis JE, Kleckner AS, Lin PJ, Gilmore NJ, Culakova E, VanderWoude AC, Mustian KM, Fernandez ID, Dunne RF, Deutsch J, Peppone LJ. Excess Body Weight and Cancer-Related Fatigue, Systemic Inflammation, and Serum Lipids in Breast Cancer Survivors. Nutr Cancer. 2021;73(9):1676-1686. doi: 10.1080/01635581.2020.1807574. Epub 2020 Aug 19.

**PMID:** 32812824

#### See Also Links

**Label:** Clinical trial summary from the National Cancer Institute's PDQ® database

**URL:** https://www.cancer.gov/publications/pdq

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Carcinoma

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M8364

- Name: Fatigue

- Relevance: HIGH

- As Found: Fatigue

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000005221

- Term: Fatigue

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T415

- Name: Omega 3 Fatty Acid

- Relevance: HIGH

- As Found: Machine

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Arm I (Low-dose Omega-3 Fatty Acid)

**Description:** Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.

Omega-3 Fatty Acid: Given PO

Placebo: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

**ID:** EG000

**Other Num at Risk:** 29

**Serious Number At Risk:** 29

**Title:** Arm I (Low-dose Omega-3 Fatty Acid)

**Group ID:** EG001

**Title:** Arm II (High-dose Omega-3 Fatty Acid)

**Description:** Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.

Omega-3 Fatty Acid: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

**ID:** EG001

**Other Num at Risk:** 35

**Serious Number At Risk:** 35

**Title:** Arm II (High-dose Omega-3 Fatty Acid)

**Group ID:** EG002

**Title:** Arm III (Placebo)

**Description:** Patients receive placebo PO BID for 6 weeks.

Placebo: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

**ID:** EG002

**Other Num Affected:** 1

**Other Num at Risk:** 33

**Serious Number At Risk:** 33

**Title:** Arm III (Placebo)

**Frequency Threshold:** 0

#### Other Events

**Term:** Pruritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (Unspecified)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 29

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 33

**Group ID:** BG003

**Value:** 97

**Units:** Participants

### Group

**ID:** BG000

**Title:** Arm I (Low-dose Omega-3 Fatty Acid)

**Description:** Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.

Omega-3 Fatty Acid: Given PO

Placebo: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

### Group

**ID:** BG001

**Title:** Arm II (High-dose Omega-3 Fatty Acid)

**Description:** Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.

Omega-3 Fatty Acid: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

### Group

**ID:** BG002

**Title:** Arm III (Placebo)

**Description:** Patients receive placebo PO BID for 6 weeks.

Placebo: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.10

**Value:** 60.62

#### Measurement

**Group ID:** BG001

**Spread:** 9.35

**Value:** 60.40

#### Measurement

**Group ID:** BG002

**Spread:** 10.94

**Value:** 58.03

#### Measurement

**Group ID:** BG003

**Spread:** 10.40

**Value:** 59.66

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 29

#### Measurement

**Group ID:** BG001

**Value:** 35

#### Measurement

**Group ID:** BG002

**Value:** 33

#### Measurement

**Group ID:** BG003

**Value:** 97

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 28

#### Measurement

**Group ID:** BG001

**Value:** 35

#### Measurement

**Group ID:** BG002

**Value:** 33

#### Measurement

**Group ID:** BG003

**Value:** 96

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 5

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 27

#### Measurement

**Group ID:** BG001

**Value:** 31

#### Measurement

**Group ID:** BG002

**Value:** 33

#### Measurement

**Group ID:** BG003

**Value:** 91

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.07

**Value:** 30.11

#### Measurement

**Group ID:** BG001

**Spread:** 7.45

**Value:** 32.31

#### Measurement

**Group ID:** BG002

**Spread:** 8.17

**Value:** 32.64

#### Measurement

**Group ID:** BG003

**Spread:** 7.34

**Value:** 31.76

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 5.81

**Value:** 91.38

#### Measurement

**Group ID:** BG001

**Spread:** 6.32

**Value:** 92.00

#### Measurement

**Group ID:** BG002

**Spread:** 7.70

**Value:** 89.70

#### Measurement

**Group ID:** BG003

**Spread:** 6.69

**Value:** 91.03

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 15

**Category Title:** Graduate Degree

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 14

#### Measurement

**Group ID:** BG003

**Value:** 45

**Category Title:** 2 or 4 year Degree / Some college

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 14

#### Measurement

**Group ID:** BG003

**Value:** 36

**Category Title:** HS / GED Degree

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** No HS Degree or GED

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 25

#### Measurement

**Group ID:** BG003

**Value:** 61

**Category Title:** Married

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 5

**Category Title:** Long Term, Committed SO

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 12

**Category Title:** Divorced

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 9

**Category Title:** Single

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 10

**Category Title:** Widowed

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 13

#### Measurement

**Group ID:** BG003

**Value:** 47

**Category Title:** Employment outside the house

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 6

**Category Title:** Self Employed

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 9

#### Measurement

**Group ID:** BG003

**Value:** 18

**Category Title:** Home Maker

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 11

#### Measurement

**Group ID:** BG003

**Value:** 26

**Category Title:** Unemployed

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 28

#### Measurement

**Group ID:** BG001

**Value:** 33

#### Measurement

**Group ID:** BG002

**Value:** 33

#### Measurement

**Group ID:** BG003

**Value:** 94

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 3

**Category Title:** No

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 17

#### Measurement

**Group ID:** BG003

**Value:** 49

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 16

#### Measurement

**Group ID:** BG003

**Value:** 48

**Category Title:** No

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 19

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 25

#### Measurement

**Group ID:** BG003

**Value:** 72

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 25

**Category Title:** No

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 9

#### Measurement

**Group ID:** BG003

**Value:** 17

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 27

#### Measurement

**Group ID:** BG001

**Value:** 29

#### Measurement

**Group ID:** BG002

**Value:** 24

#### Measurement

**Group ID:** BG003

**Value:** 80

**Category Title:** No

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Description:** Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese".
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** BMI
**Unit of Measure:** kg/m^2
### Measure 6
**Description:** The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. Essentially as used in oncology, the KPS is a measure of time to death. A higher score is favorable. There are 3 general categories which are broken down into 11 specific criteria. Scale range is from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease). The scale increases in units of 10.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Karnofsky Performance Status (KPS)
**Unit of Measure:** Karnofsky Performance Scale
### Measure 7
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Education Level
**Unit of Measure:** Participants
### Measure 8
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Marital Status
**Unit of Measure:** Participants
### Measure 9
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Employment Status (Current)
**Unit of Measure:** Participants
### Measure 10
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Previous Treatment - Surgery
**Unit of Measure:** Participants
### Measure 11
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Previous Treatment - Chemotherapy
**Unit of Measure:** Participants
### Measure 12
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Previous Treatment - Radiation
**Unit of Measure:** Participants
### Measure 13
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Previous Treatment - Hormone Therapy
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** Luke_Peppone@urmc.rochester.edu
**Organization:** University of Rochester Medical Center
**Phone:** 585-275-7827
**Title:** Luke J. Peppone, PhD, MPH. Assistant Professor
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.4843
**Estimate Comment:** 
**Group Description:** BFI-SF
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 0.1666
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.6763
**Statistical Comment:** Based on a contrast using the three-arm ANCOVA.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.4567
**Estimate Comment:** 
**Group Description:** BFI-SF
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 0.1329
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.6936
**Statistical Comment:** Based on a contrast using the three-arm ANCOVA.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 3.8065
**Estimate Comment:** 
**Group Description:** MFSI-SF
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 0.9826
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.0831
**Statistical Comment:** Based on a contrast using the three-arm ANCOVA.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 3.5448
**Estimate Comment:** 
**Group Description:** MFSI-SF
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 0.4016
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 2.9898
**Statistical Comment:** Based on a contrast using the three-arm ANCOVA.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.37
- **Spread:** 
- **Upper Limit:** -2.96
- **Value:** -3.66
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -4.31
- **Spread:** 
- **Upper Limit:** -3.05
- **Value:** -3.68
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -3.65
- **Spread:** 
- **Upper Limit:** -2.33
- **Value:** -2.99
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -16.55
- **Spread:** 
- **Upper Limit:** -5.50
- **Value:** -11.03
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -18.82
- **Spread:** 
- **Upper Limit:** -9.05
- **Value:** -13.93
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -16.07
- **Spread:** 
- **Upper Limit:** -5.82
- **Value:** -10.94
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine).

MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline to 6 weeks
**Title:** Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.

Omega-3 Fatty Acid: Given PO

Placebo: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies
**ID:** OG000
**Title:** Arm I (Low-dose Omega-3 Fatty Acid)
##### Group
**Description:** Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.

Omega-3 Fatty Acid: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies
**ID:** OG001
**Title:** Arm II (High-dose Omega-3 Fatty Acid)
##### Group
**Description:** Patients receive placebo PO BID for 6 weeks.

Placebo: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies
**ID:** OG002
**Title:** Arm III (Placebo)
### Participant Flow Module
#### Group
**Description:** Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.

Omega-3 Fatty Acid: Given PO

Placebo: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies
**ID:** FG000
**Title:** Arm I (Low-dose Omega-3 Fatty Acid)
#### Group
**Description:** Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.

Omega-3 Fatty Acid: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies
**ID:** FG001
**Title:** Arm II (High-dose Omega-3 Fatty Acid)
#### Group
**Description:** Patients receive placebo PO BID for 6 weeks.

Placebo: Given PO

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies
**ID:** FG002
**Title:** Arm III (Placebo)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Personal Issues
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Too Many Forms
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Feeling Overwhelmed
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Disliked Intervention
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Changed Mind
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Study Related Symptoms
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Absence of Symptoms
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Other Medical Reason
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** No Reason
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 37
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 36
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 35
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 29
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 35
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 33
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
**Has Results:** True