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NCT01385137 · ClinicalTrials.gov registry record · Phase 3
S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy
A Phase 3 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 262
- Enrollment target
NCT01385137: Completed Phase 3 study, sponsored by SWOG Cancer Research Network.
NCT01385137 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 262 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01385137, a Phase 3 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 262 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- OTHER placebo
- DIETARY_SUPPLEMENT omega-3 fatty acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT01385137 record still lists
NCT01385137 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01385137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01385137 about?
NCT01385137 is a clinical study titled "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 sti...
What is the current status of trial NCT01385137?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 262 participants. The study started on 2012-02. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01385137?
The interventions under investigation include: placebo (OTHER), omega-3 fatty acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01385137?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01385137's enrollment target sits among peer trials
262 1228th of 2000 higher than 773 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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