S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy

Phase 3

Completed

Conditions: Arthralgia
Breast Cancer
Pain

Registration Number: NCT01385137

Lead Sponsor: SWOG Cancer Research Network

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 262

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score	12 weeks post-registration	Linear regression model-adjusted week 12 mean score by treatment group. Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug	Up to 25 weeks	Only adverse events that are possibly, probably or definitely related to study drug are reported.
Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score	12 weeks post-registration	Linear regression model-adjusted week 12 mean score by treatment group The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate higher symptom burden.
Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score	12 weeks post-registration	Linear regression model-adjusted week 12 mean score by treatment group. Higher scores represent higher symptom burden. Range is 0 to 100.
Week 12 Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Score	12 weeks post-registration	FACT-ES measures physical, social and family, emotional, and functional well-being and endocrine symptoms. The FACT scaleshave five response levels ("not at all" to "very much"), where higher scores reflect better well-being and fewer symptoms. This scale provided a measure of the broader impact of join pain and stiffness symptoms. Score range is 0 to 220.

Trial Locations

Locations (292): Providence Cancer Center at Providence Hospital
🇺🇸
Mobile, Alabama, United States
Alaska Regional Hospital Cancer Center
🇺🇸
Anchorage, Alaska, United States
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
🇺🇸
Fairbanks, Alaska, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Highlands Oncology Group - Springdale
🇺🇸
Rogers, Arkansas, United States
Kaiser Permanente Medical Center - Anaheim/Orange County
🇺🇸
Anaheim, California, United States
Kaiser Permanente - Deer Valley
🇺🇸
Antioch, California, United States
Kaiser Permanente Medical Center - Baldwin Park
🇺🇸
Baldwin Park, California, United States
Kaiser Permanente Medical Center - Bellflower
🇺🇸
Bellflower, California, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸
Berkeley, California, United States
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Providence Cancer Center at Providence Hospital
🇺🇸Mobile, Alabama, United States