S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy
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|ClinicalTrials.gov Identifier: NCT01385137|
Recruitment Status : Completed
First Posted : June 29, 2011
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Arthralgia Breast Cancer Pain||Dietary Supplement: omega-3 fatty acid Other: placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||262 participants|
|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|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||March 2014|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385137
Show 292 Study Locations
|Study Chair:||Dawn Hershman, MD||Herbert Irving Comprehensive Cancer Center|
|Principal Investigator:||Laurence H. Baker, DO, FACOI||University of Michigan Rogel Cancer Center|