S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy
Condition: Arthralgia; Breast Cancer; Pain
MeSH terms: Breast Neoplasms; Arthralgia
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and
      bone pain and stiffness caused by hormone therapy in patients with breast cancer.

      PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in
      treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III
      breast cancer receiving hormone therapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess whether omega-3-fatty acid as compared to placebo causes a reduction in worst
           joint pain and/or stiffness at 12 weeks, as measured by the modified Brief Pain
           Inventory (BPI), in women with early-stage breast cancer and aromatase inhibitor
           (AI)-associated arthralgia.

      Secondary

        -  To assess the proportion of patients who report improved versus deteriorated joint pain
           with omega-3-fatty acid versus placebo.

        -  To assess the proportion of patients who report improved versus deteriorated joint
           stiffness with omega-3-fatty acid versus placebo.

        -  To assess whether patients receiving omega-3-fatty acid compared to placebo have
           decreased analgesic use and increased AI adherence.

        -  To assess whether patients receiving omega-3-fatty acid compared to placebo have
           improved functioning, pain, and stiffness in the knees/hips (as measured by the Western
           Ontario and McMaster Universities Osteoarthritis, WOMAC) score.

        -  To assess whether patients receiving omega-3-fatty acid have improved functioning, pain,
           and stiffness in the hands (as measured by the Modified Score for the Assessment and
           Quantification of Chronic Rheumatoid Affections of the Hands, M-SACRAH).

        -  To assess whether patients receiving omega-3-fatty acid compared to placebo have
           improved functional quality of life as measured by the Functional Assessment of Cancer
           Therapy-Endocrine Subscale (FACT-ES) Trial Outcome Index (TOI).

        -  To assess whether patients receiving omega-3-fatty acid report changes for the better
           versus worse compared to placebo as measured by the Global Rating of Change Scale.

        -  To identify minimally important change in the WOMAC, M-SACRAH, and the FACT-ES Trial
           Outcome Index (TOI) using "a little better" or "a little worse" responses on the
           patient-reported global rating of change in joint pain and joint stiffness.

        -  To assess whether patients receiving omega-3-fatty acid compared to placebo have an
           improved lipid profile as measured by triglycerides, HDL, and LDL.

        -  To assess the toxicity of omega-3-fatty acid compared to placebo in this setting.

        -  To assess whether there is a difference in serum-free and total estradiol levels before
           and after treatment with omega-3-fatty acid compared to placebo.

        -  To explore whether CYP19A1 genotype correlates with severity of joint symptoms or
           predicts response to omega-3-fatty acid. (exploratory)

        -  To explore changes in hormonal and inflammatory serum biomarkers, such as IL6, TNF-α,
           and CRP.

        -  To assess whether there is a relationship between change in serum docosahexaenoic acid
           (DHA) and EPA and resolution of joint symptoms.

        -  To establish a cohort of patients (placebo group) to better characterize the natural
           history of the syndrome.

      OUTLINE: This is a multicenter study. Patients are stratified according to prior
      osteoarthritis (yes vs no) and prior taxane use (yes vs no). Patients are randomized to 1 of
      2 treatment arms.

        -  Arm I: Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily
           (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity.

        -  Arm II: Patients receive oral placebo BID or TID for 24 weeks in the absence of disease
           progression or unacceptable toxicity.

      Patients undergo blood sample collection at baseline and at 12 and 24 weeks for biomarker and
      DNA analysis.

      Patients complete the Brief Pain Inventory Short Form (BPI-SF), the Western Ontario and
      McMaster Universities Osteoarthritis (WOMAC) Index, the Modified-Score for the Assessment and
      Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the FACT-ES Trial
      Outcome Index, and the Omega-3-fatty acid Dietary Intake questionnaires at baseline and at 6,
      12, and 24 weeks.
    

Intervention name(s): omega-3 fatty acid; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Given orally; Given orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; pain; arthralgia