Trial of Oral Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias
Status:
Withdrawn
Trial end date:
2018-12-14
Target enrollment:
Participant gender:
Summary
This is a single center, double-blinded, placebo-controlled, randomized Phase II trial to
determine whether oral hyaluronic acid will prevent aromatase inhibitor (AI)-associated
arthralgias. Subjects must have ER/PR-positive breast cancer tumor with history of aromatase
inhibitor-associated musculoskeletal symptoms (AIMSS) which resolved after cessation of their
AI (anastrazole or letrozole) within 90 days of enrollment. Subjects will be stratified by
initial AI, thus within each initial AI, subjects will be randomized to receive either the
experimental treatment (hyaluronic acid) or placebo. Subjects will begin the assigned
treatment for 2 weeks prior to transitioning to the second AI. Evaluations will be taken at
baseline, 6 weeks (1 month on study drug and AI), 14 weeks (3 months on study drug and AI),
and at 26 weeks (6 months on study drug and AI). Treatment with hyaluronic acid and placebo
will last for 26 weeks total.