Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 200
Summary
- Conditions
- Arthralgia
- Breast Neoplasms
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: I. To determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 PUFA) supplementation in preventing aromatase inhibitor-induced arthralgias (AIIAs). SECONDARY OBJECTIVES: I. To prospectively define the population most at risk for developing AIIAs by the identifi...
PRIMARY OBJECTIVES: I. To determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 PUFA) supplementation in preventing aromatase inhibitor-induced arthralgias (AIIAs). SECONDARY OBJECTIVES: I. To prospectively define the population most at risk for developing AIIAs by the identification and validation of genetic risk predictors and to develop a single nucleotide polymorphism (SNP)/gene profile predictive of treatment intervention response. OUTLINE: Patients are randomized to 1 of 2 groups. Group I: Patients receive omega-3 fatty acid supplementation orally (PO) once daily (QD) for 6 months. Group II: Patients receive placebo PO QD for 6 months. After completion of study, patients will be followed up periodically.
Tracking Information
- NCT #
- NCT02831582
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Maryam Lustberg, MD Ohio State University Comprehensive Cancer Center
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