NCT02831582

Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer

Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial studies the use of omega-3 fatty acid supplementation in preventing aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3 supplementation may help relieve moderate to severe bone pain and improve joint symptoms caused by aromatase inhibitor-induced arthralgias.

Detailed 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 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.

Conditions

• Arthralgia
• Breast Neoplasms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3 Fatty Acid	Given PO.
OTHER	Placebo	Given PO.

Timeline

• Start date: 2016-10-12
• Primary completion: 2021-12-11
• Completion: 2021-12-11
• First posted: 2016-07-13
• Last updated: 2023-02-27

Locations

3 sites across 1 country: United States