Prevention of Aromatase Inhibitor-Induced Joint Symptoms With Omega 3 Fatty Acid Supplementation: a Randomized Placebo Controlled Pilot Study
I. To assess the feasibility of evaluating joint symptoms in postmenopausal women with
breast cancer randomized to n-3 PUFA (omega-3 fatty acid) vs. placebo supplementation using
the Functional Assessment of Cancer Therapy-Breast (FACT-B) and endocrine subscale
(FACT-ES), Brief Pain Inventory (BPI) and Stanford's Health Assessment -Disability Index
(HAS) during the first 6 months of adjuvant aromatase inhibitor (AI) therapy.
II. To preliminarily evaluate the efficacy of n-3 PUFA vs. placebo supplementation on AI
induced joint symptoms.
III. To explore blood and imaging based biomarkers (plasma and red blood cell [RBC] levels
of n-3 PUFAs, inflammatory cytokines and receptors, and intra-articular tenosynovial
inflammation by musculoskeletal magnetic resonance imaging [MRI] imaging) of AI-induced
joint symptoms in women on AI therapy randomized to n-3 PUFAs vs. placebo supplementation.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive omega-3 fatty acid orally (PO) once daily (QD) for 6 months in the
absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 6 months in the absence of disease progression or
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Pain score change after 6 months (6 months -baseline) based on the FACT-B/ES instrument
Pain scores based on FACT-B/ES, HAS and BPI will be plotted over time for each arm. Agreement between HAS, BPI-short and FACT-B/ES evaluated using Altman and Bland plot after proper data transformation. Also, Linear Mixed model used to explore if the pain scores are different at 3 and 6 months. Logistic regression models used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups, with potential covariates including age, body mass index, baseline pain scores (0 month), prior chemotherapy and other variables.
baseline, 6 months
Maryam Lustberg, MD
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|