Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-07 @ 10:34 AM
Study NCT ID:
NCT03384095
Status:
WITHDRAWN
Last Update Posted:
2019-01-02
First Post:
2017-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Oral Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias
Sponsor:
Erin Newton
Organization:
Study Overview
Official Title:
Single Center, Placebo-Controlled Trial of Oral High-Molecular Weight Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias
Status:
WITHDRAWN
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study abandoned prior to opening to accrual or study start
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: