N/A Completed N=108 Randomized Double-blind Supportive Care

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

Breast Cancer · Cancer · Fatigue

Source: ClinicalTrials.gov NCT02352779 ↗

Enrolled (actual)

108

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcomePrimary: 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 — -3.66; -3.68; -2.99; -11.03 units on a scale — p=0.1666

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	-3.66; -3.68; -2.99; -11.03; -13.93; -10.94	0.1666

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02352779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.