S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy
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.
|Arthralgia Breast Cancer Pain||Dietary Supplement: omega-3 fatty acid Other: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
|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|
- Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score [ Time Frame: 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
- Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
|Study Start Date:||February 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Dietary Supplement: omega-3 fatty acid
Placebo Comparator: Arm II
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01385137
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|Study Chair:||Dawn Hershman, MD||Herbert Irving Comprehensive Cancer Center|
|Principal Investigator:||Laurence H. Baker, DO, FACOI||University of Michigan Cancer Center|