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

July 5, 2017 updated by: Gary Morrow

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Wichita NCORP
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Cancer Research Consortium of West Michigan
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester NCORP Research Base
    • Ohio
      • Dayton, Ohio, United States, 45420
        • Dayton NCORP
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System NCORP
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Wisconsin NCORP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (low-dose omega-3 fatty acid)
Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Placebo
Given PO
Other Names:
  • PLCB
Other: Questionnaire Administration
Ancillary studies
Dietary supplement: Omega-3 Fatty Acid
Given PO
Other Names:
  • O3FA
  • Omega-3 Fatty Acids
  • Omega-3 PUFA
Experimental: Arm II (high-dose omega-3 fatty acid)
Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
Dietary supplement: Omega-3 Fatty Acid
Given PO
Other Names:
  • O3FA
  • Omega-3 Fatty Acids
  • Omega-3 PUFA
Placebo Comparator: Arm III (placebo)
Patients receive placebo PO BID for 6 weeks.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Placebo
Given PO
Other Names:
  • PLCB
Other: Questionnaire Administration
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value
Time Frame: Baseline to 6 weeks

BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine).

MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue).
Baseline to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gary Morrow

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URCC13091 (Other Identifier: University of Rochester NCORP Research Base)
  • UG1CA189961 (U.S. NIH Grant/Contract)
  • NCI-2014-01191 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • URCC-13091 (Other Identifier: CTEP)
  • U10CA037420 (U.S. NIH Grant/Contract)
  • R03CA175599 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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