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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Breast Neoplasm Female, Arthralgia

In brief

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.

Key facts

Study ID

NCT03384095

Run by

Erin Newton

People needed

0

Starts

2018-12-14

Expected to finish

2018-12-14

Last updated by the study team

2019-01-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old.
• Had been taking anastrazole or letrozole, and discontinued it within the past 90 days due to pain and/or stiffness. The AI-related pain/stiffness must have resolved.
• Prior tamoxifen use is allowed.
• A prior switch from exemestane is allowed.
• Women who have undergone a total mastectomy or breast conserving surgery for Stage 0-3 breast cancer +/- chemotherapy, +/- antiHer2Neu therapy, +/- radiotherapy.
• Must have ER and/or PR positive tumors.
• Women who are postmenopausal by the presence of natural amenorrhea ≥ 12 months or by ovarian ablation (bilateral oophorectomy, radiation, or administration of a gonadotropin-releasing hormone agonist).
• Eastern Cooperative Oncology Group Performance Score (ECOG PS) 0-3 (Appendix II).
• Patients may or may not be taking non-opioid analgesics.
• Adequate renal and hepatic function:
• i) Include only subjects with AST and ALT < 2.0 × ULN; AP < 1.5 × ULN; total bilirubin < 1.2 × ULN ii) Include only subjects with as calculated creatinine clearance (CrCl) > 60 mL/min determined by the central laboratory using the modified Cockcroft-Gault equation; blood urea nitrogen (BUN) < 1.5 × upper limit of normal (ULN)
• Written informed consent from subject and ability for subject to comply with the requirements of the study.

You may not qualify if…

• Presence of residual or recurrent cancer.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• Consumption of HA-containing supplements in the four weeks prior to study.
• Known allergy to microcrystalline cellulose or HA. Any questionable reaction to injected HA will be thoroughly investigated.
• Prolonged systemic corticosteroid treatment, except for topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airway diseases), eye drops or local insertion (i.e., intra-articular). A short duration of systemic corticosteroids is allowed but not within 30 days prior to registration.
• Self-reported compliance issues and lack of regular prescription filling.
• Previous diagnosis of fibromyalgia and/or rheumatoid arthritis.

Where it is running

• Indiana University Health North Hospital — Carmel, Indiana, United States
• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Spring Mill Medical Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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