N/A
N=108
Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
Breast Carcinoma · Cancer · Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT02352779 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: 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 units on a scale — p=0.1666
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Omega-3 Fatty Acid (Dietary_supplement); Placebo (Other); Questionnaire Administration (Other); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gary Morrow
- Primary completion
- Feb 2016
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 |
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.
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
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.