Cancer Clinical Trial
Official title:
Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue
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.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
I. To determine the adherence and adverse events for the two omega-3 supplementation
regimens (1.65 g/day and 3.3 g/day) compared to placebo.
II. To collect preliminary statistical data (mean changes and standard deviations) on two
omega-3 supplementation regimens (1.65 g/day and 3.3 g/day) compared to placebo for reducing
inflammation (C-reactive protein [CRP], interleukin 6 [IL-6], and tumor necrosis factor
[TNF]-alpha) in fatigued breast cancer survivors.
TERTIARY OBJECTIVES:
I. To explore the effects of the two omega-3 supplement regimens on serum fatty acid levels
compared to placebo.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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