Spots Global Cancer Trial Database for Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer

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Trial Identification

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

Official Title: Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation

Study ID: NCT02831582

Conditions

Arthralgia

Breast Neoplasms

Interventions

Omega-3 Fatty Acid

Placebo

Study Description

Brief 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.