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

Cancer Clinical Trial

Official title:

Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352779
• Other study ID #: URCC13091
• Secondary ID: NCI-2014-01191UR
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2015
• Last updated: January 3, 2017
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Cancer
• Fatigue

Intervention

Dietary Supplement:
• Omega-3 Fatty Acid
Given PO

Other:
• Placebo
Given PO
• Questionnaire Administration
Ancillary studies
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Dayton NCORP	Dayton	Ohio
United States	Cancer Research Consortium of West Michigan	Grand Rapids	Michigan
United States	Greenville Health System NCORP	Greenville	South Carolina
United States	Wisconsin NCORP	Marshfield	Wisconsin
United States	University of Rochester NCORP Research Base	Rochester	New York
United States	Wichita NCORP	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in serum fatty acid level	The differences between the three arms will be evaluated in time trajectory of the serum fatty acid levels with a linear mixed-effects model. The three time points (weeks 0, 3, and 6) will be the response. Comparisons of least squares means between arms will be performed using the Tukey multiple comparisons procedure.	Baseline up to 6 weeks	No
Primary	Mean change and standard deviation in cancer-related fatigue (CRF) , assessed using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFI-SF)	Analysis of covariance (ANCOVA) models will be used with baseline as the covariate and follow-up as the response to assess the mean changes and standard deviations between the groups. Separate ANCOVA models will be used for the BFI-SF and MFI-SF. The Spearman Rank correlation will be calculated between the change in serum omega-3 fatty acid levels and changes in BFI-SF and MFI-SF to examine the dose-response effect.	Baseline to 6 weeks	No
Secondary	Adherence for the two omega-3 fatty acid supplementation regimens compared to placebo, measured by the Morisky Medication Adherence Questionnaire	A chi-square will be used to test the difference in adherence between each omega-3 fatty acid arm versus placebo. The Morisky Medication Adherence Questionnaire will be administered and used to categorize participants into three groups: high, moderate, and low adherence. Adherence differences between actual and believed group assignment will be examined.	Up to 6 weeks	No
Secondary	Incidence of adverse events reported using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0	Chi-square statistic will be calculated to test the difference in adverse events between each omega-3 fatty acid arm versus placebo.	Up to 6 weeks	Yes
Secondary	Mean change and standard deviation in inflammation, measured by inflammatory marker (CRP, IL-6, TNF-alpha).	ANCOVA models will be used with baseline as the covariate and follow-up as the response to assess the mean changes and standard deviations from baseline to follow-up between the groups. Separate ANCOVA models will be used for each inflammatory marker (CRP, IL-6, TNF-alpha).	Baseline up to 6 weeks	No