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

Recruiting in Palo Alto (17 mi)

+291 other locations

Overseen byLaurence H. Baker, DO, FACOI

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Southwest Oncology Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Laurence H. Baker, DO, FACOI

Principal Investigator

University of Michigan Rogel Cancer Center

Dawn Hershman, MD

Principal Investigator

Herbert Irving Comprehensive Cancer Center

Eligibility Criteria

Inclusion Criteria

Histologically confirmed primary invasive adenocarcinoma of the breast

Stage I, II, or IIIA disease

No metastatic disease

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Treatment Details

Interventions

Omega-3 Fatty Acid (Dietary Supplement)
Placebo (Hormone Therapy)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm IExperimental Treatment1 Intervention

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.

Group II: Arm IIPlacebo Group1 Intervention

Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.