Clinical trial · Interventional
Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue
NCT02352779CI-TRIAL-00028980completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Omega-3 Fatty Acid | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Dietary Supplement: Omega-3 Fatty Acid
- Other: Placebo
- Other: Questionnaire Administration
- Other: Laboratory Biomarker Analysis
- type
- EXPERIMENTAL
- label
- Arm II (high-dose omega-3 fatty acid)
- description
- Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
- interventionNames
- Dietary Supplement: Omega-3 Fatty Acid
- Other: Questionnaire Administration
- Other: Laboratory Biomarker Analysis
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKleckner 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
- DERIVEDInglis 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