Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer, Breast Carcinoma, Fatigue

Intervention / Treatment
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* Dietary Supplement: Omega-3 Fatty Acid
* Other: Placebo
* Other: Questionnaire Administration
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (low-dose omega-3 fatty acid)<br>Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks. | Dietary Supplement: Omega-3 Fatty Acid<br>* Given PO<br>* Other names: Omega-3 PUFA;Other: Placebo<br>* Given PO<br>* Other names: PLCB;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|
| Experimental: Arm II (high-dose omega-3 fatty acid)<br>Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks. | Dietary Supplement: Omega-3 Fatty Acid<br>* Given PO<br>* Other names: Omega-3 PUFA;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|
| Placebo Comparator: Arm III (placebo)<br>Patients receive placebo PO BID for 6 weeks. | Other: Placebo<br>* Given PO<br>* Other names: PLCB;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | Baseline to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Survivor