Status:
WITHDRAWN
Trial of Oral Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias
Lead Sponsor:
Erin Newton
Collaborating Sponsors:
Indiana University
NOW Foods
Conditions:
Breast Neoplasm Female
Arthralgia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
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 a...
Eligibility Criteria
Inclusion
- Study Population ER/PR-Positive Breast Cancer Subjects whose AIMSS resolved with cessation of their AI and are candidates for switching to a different AI and who meet the inclusion and exclusion criteria will be eligible for participation in this study.
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03384095
Start Date
December 14 2018
End Date
December 14 2018
Last Update
January 2 2019
Active Locations (4)
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1
Indiana University Health North Hospital
Carmel, Indiana, United States, 46032
2
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
3
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
4
Spring Mill Medical Center
Indianapolis, Indiana, United States, 46290