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

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

I. To determine the adherence and adverse events for the two omega-3 supplementation
regimens (1.65 g/day and 3.3 g/day) compared to placebo.

II. To collect preliminary statistical data (mean changes and standard deviations) on two
omega-3 supplementation regimens (1.65 g/day and 3.3 g/day) compared to placebo for reducing
inflammation (C-reactive protein [CRP], interleukin 6 [IL-6], and tumor necrosis factor
[TNF]-alpha) in fatigued breast cancer survivors.

TERTIARY OBJECTIVES:

I. To explore the effects of the two omega-3 supplement regimens on serum fatty acid levels
compared to placebo.

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.

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