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

Gary Morrow

Status: Completed

Conditions: Cancer; Fatigue; Breast Carcinoma

Treatments: Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Questionnaire Administration; Dietary Supplement: Omega-3 Fatty Acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02352779

URCC-13091 (Other Identifier)

UG1CA189961 (U.S. NIH Grant/Contract)

U10CA037420 (U.S. NIH Grant/Contract)

R03CA175599 (U.S. NIH Grant/Contract)

NCI-2014-01191 (Registry Identifier)

URCC13091 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups, including a placebo group

Arm I (low-dose omega-3 fatty acid)

Experimental group

Description:

Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.

Treatment:

Dietary Supplement: Omega-3 Fatty Acid

Other: Laboratory Biomarker Analysis

Other: Placebo

Other: Questionnaire Administration

Arm II (high-dose omega-3 fatty acid)

Experimental group

Description:

Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.

Treatment:

Dietary Supplement: Omega-3 Fatty Acid

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Arm III (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO BID for 6 weeks.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Placebo

Other: Questionnaire Administration