At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 262 enrolled
Drug / intervention
omega-3 fatty acid +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating omega-3 fatty acid and placebo for Arthralgia and 2 related conditions. Completed, enrolled 262 participants across 292 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthralgia, Breast Cancer, Pain
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartFeb 2012
Primary CompletionDec 2013
Study CompletionMar 2014
TodayJul 2026
First PostedJun 29, 2011
Enrollment StartFeb 1, 2012
Primary CompletionDec 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.0 years ago
Interventions
omega-3 fatty aciddietary
Given orally
placeboother
Given orally