NCT03384095

Trial of Oral Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias

Single Center, Placebo-Controlled Trial of Oral High-Molecular Weight Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Erin Newton · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective To determine whether oral HA will prevent AI-induced arthralgias and preserve physical function. Secondary Objectives 1. To explore whether oral HA will have an acceptable safety and tolerability profile. 2. To determine whether oral HA will prevent other AI associated symptoms as assessed by patient reported outcomes (PRO's). 3. To assess how many of the subjects are 90% compliant with taking the HA as directed. Exploratory Objective To determine if mi486, (a microRNA enriched in skeletal muscle) and other biomarkers associated with AIMSS (TNF, IL-6, IL-17) vary with the administration of HA.

Conditions

• Breast Neoplasm Female
• Arthralgia

Interventions

Type	Name	Description
DRUG	Hyaluronic Acid (HA)	Dosage form: hyaluronic capsules; Dose: 100 mg; Frequency: twice daily; Duration: 26 weeks
OTHER	Placebo	Dosage form: microcrystalline cellulose (MCC) capsules; Dose: approx. 100 mg (determined by weight of HA counterpart); Frequency: twice daily; Duration: 26 weeks

Timeline

• Start date: 2018-12-14
• Primary completion: 2018-12-14
• Completion: 2018-12-14
• First posted: 2017-12-27
• Last updated: 2019-01-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study