Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
NCT ID: NCT02352779
Last Updated: 2017-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2015-02-28
2016-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
Omega-3 Fatty Acid
Given PO
Placebo
Given PO
Questionnaire Administration
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Arm II (high-dose omega-3 fatty acid)
Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Omega-3 Fatty Acid
Given PO
Questionnaire Administration
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Arm III (placebo)
Patients receive placebo PO BID for 6 weeks.
Placebo
Given PO
Questionnaire Administration
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Omega-3 Fatty Acid
Given PO
Placebo
Given PO
Questionnaire Administration
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gary Morrow
OTHER
Responsible Party
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Gary Morrow
Principal Investigator, URCC NCORP Research Base
Principal Investigators
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Luke Peppone
Role: PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base
Locations
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Wichita NCORP
Wichita, Kansas, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States
University of Rochester NCORP Research Base
Rochester, New York, United States
Dayton NCORP
Dayton, Ohio, United States
Greenville Health System NCORP
Greenville, South Carolina, United States
Wisconsin NCORP
Marshfield, Wisconsin, United States
Countries
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References
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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.
Inglis 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.
Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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NCI-2014-01191
Identifier Type: REGISTRY
Identifier Source: secondary_id
URCC13091
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-13091
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-13091
Identifier Type: OTHER
Identifier Source: secondary_id
URCC13091
Identifier Type: -
Identifier Source: org_study_id
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