Expired Study
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Wichita, Kansas 67214


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02352779


Primary Contact:

Principal Investigator
Luke Peppone
University of Rochester NCORP Research Base


Backup Contact:

N/A


Location Contact:

Wichita, Kansas 67214
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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