Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue
6 other identifiers
interventional
108
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
August 8, 2017
CompletedAugust 8, 2017
July 1, 2017
1 year
January 28, 2015
February 3, 2017
July 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
Study Arms (3)
Arm I (low-dose omega-3 fatty acid)
EXPERIMENTALPatients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Arm II (high-dose omega-3 fatty acid)
EXPERIMENTALPatients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Arm III (placebo)
PLACEBO COMPARATORPatients receive placebo PO BID for 6 weeks.
Interventions
Given PO
Ancillary studies
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gary Morrowlead
- National Cancer Institute (NCI)collaborator
Study Sites (6)
Wichita NCORP
Wichita, Kansas, 67214, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, 49503, United States
University of Rochester NCORP Research Base
Rochester, New York, 14642, United States
Dayton NCORP
Dayton, Ohio, 45420, United States
Greenville Health System NCORP
Greenville, South Carolina, 29605, United States
Wisconsin NCORP
Marshfield, Wisconsin, 54449, United States
Related Publications (2)
Kleckner AS, Kleckner IR, Culakova E, Wojtovich AP, Klinedinst NJ, Kerns SL, Hardy SJ, Inglis JE, Padula GDA, Mustian KM, Janelsins MC, Dorsey SG, Saligan LN, Peppone LJ. Exploratory Analysis of Associations Between Whole Blood Mitochondrial Gene Expression and Cancer-Related Fatigue Among Breast Cancer Survivors. Nurs Res. 2022 Sep-Oct 01;71(5):411-417. doi: 10.1097/NNR.0000000000000598. Epub 2022 Apr 13.
PMID: 35416182DERIVEDInglis JE, Kleckner AS, Lin PJ, Gilmore NJ, Culakova E, VanderWoude AC, Mustian KM, Fernandez ID, Dunne RF, Deutsch J, Peppone LJ. Excess Body Weight and Cancer-Related Fatigue, Systemic Inflammation, and Serum Lipids in Breast Cancer Survivors. Nutr Cancer. 2021;73(9):1676-1686. doi: 10.1080/01635581.2020.1807574. Epub 2020 Aug 19.
PMID: 32812824DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Luke J. Peppone, PhD, MPH. Assistant Professor
- Organization
- University of Rochester Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Luke Peppone
University of Rochester NCORP Research Base
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, URCC NCORP Research Base
Study Record Dates
First Submitted
January 28, 2015
First Posted
February 2, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2016
Study Completion
April 1, 2016
Last Updated
August 8, 2017
Results First Posted
August 8, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share