S0927: Omega-3-Fatty Acid Supplements in Treating Muscle and Bone Pain and Stiffness in Pts W/Stage I, II, or III Breast Cancer Receiving Hormone Therapy

Breast Cancer Clinical Trial

Official title: S0927: A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness In Women With Early Stage Breast Cancer, Phase III

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms
• Pain

• NCT number: NCT01385137
• Study type: Interventional
• Source: Southwest Oncology Group
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Completion date: March 2014