Clinical trial NCT02352779: Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
Official title: Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Cancer
Fatigue
Keywords: Cancer Survivor
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-02-02
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Wichita NCORP
state: Kansas
city: Grand Rapids
country: United States
facility: Cancer Research Consortium of West Michigan
state: Michigan
city: Rochester
country: United States
facility: University of Rochester NCORP Research Base
state: New York
city: Dayton
country: United States
facility: Dayton NCORP
state: Ohio
city: Greenville
country: United States
facility: Greenville Health System NCORP
state: South Carolina
city: Marshfield
country: United States
facility: Wisconsin NCORP
state: Wisconsin
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Luke Peppone
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.