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

Not Applicable

Completed

• Conditions: Cancer; Breast Carcinoma; Fatigue
• Interventions: Dietary Supplement: Omega-3 Fatty Acid; Other: Placebo; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02352779
• Lead Sponsor: Gary Morrow

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.

Study Timeline

• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-01-30
• Study Start: 2015-02
• Study First Posted: 2015-02-02
• Primary Completion: 2016-02
• Study Completion: 2016-04
• Results First Submitted: 2017-02-03
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Results First Posted: 2017-08-08
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (low-dose omega-3 fatty acid)	Placebo	Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Arm I (low-dose omega-3 fatty acid)	Laboratory Biomarker Analysis	Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Arm III (placebo)	Laboratory Biomarker Analysis	Patients receive placebo PO BID for 6 weeks.
Arm I (low-dose omega-3 fatty acid)	Omega-3 Fatty Acid	Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Arm I (low-dose omega-3 fatty acid)	Questionnaire Administration	Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Arm II (high-dose omega-3 fatty acid)	Omega-3 Fatty Acid	Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Arm II (high-dose omega-3 fatty acid)	Questionnaire Administration	Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Arm II (high-dose omega-3 fatty acid)	Laboratory Biomarker Analysis	Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Arm III (placebo)	Placebo	Patients receive placebo PO BID for 6 weeks.
Arm III (placebo)	Questionnaire Administration	Patients receive placebo PO BID for 6 weeks.

Primary Outcome Measures

Name	Time	Method
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	Baseline to 6 weeks	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).

Trial Locations

Locations (6)

Cancer Research Consortium of West Michigan; 🇺🇸 Grand Rapids, Michigan, United States

Dayton NCORP; 🇺🇸 Dayton, Ohio, United States

Wisconsin NCORP; 🇺🇸 Marshfield, Wisconsin, United States

Wichita NCORP; 🇺🇸 Wichita, Kansas, United States

University of Rochester NCORP Research Base; 🇺🇸 Rochester, New York, United States

Greenville Health System NCORP; 🇺🇸 Greenville, South Carolina, United States