NCT02352779

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

Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Gary Morrow · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma
• Cancer
• Fatigue

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3 Fatty Acid	Given PO
OTHER	Placebo	Given PO
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-02-01
• Completion: 2016-04-01
• First posted: 2015-02-02
• Last updated: 2017-08-08
• Results posted: 2017-08-08

Locations

6 sites across 1 country: United States