A Phase 2 interventional study of Hyaluronic Acid (HA) and Placebo in Breast Neoplasm Female and Arthralgia, sponsored by Erin Newton. Withdrawn at 4 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-02.
Sponsored by Erin Newton · Phase 2, Interventional, and Supportive care
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.
Primary Objective To determine whether oral HA will prevent AI-induced arthralgias and preserve physical function.
Secondary Objectives
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 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
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)
Exclusion Criteria
Subjects in this arm will be given 100 mg of hyaluronic acid in capsule form. Subject in this arm will be asked to 1 capsule take twice daily for 26 weeks.
Drug: Hyaluronic Acid (HA)
Subjects in this arm will be given a placebo comparator capsule that is identical to the hyaluronic capsule containing microcrystalline cellulose as the sole ingredient. Subjects in this arm will be asked to take 1 capsule twice daily for 26 weeks.
Other: Placebo
Dosage form: hyaluronic capsules; Dose: 100 mg; Frequency: twice daily; Duration: 26 weeks
Dosage form: microcrystalline cellulose (MCC) capsules; Dose: approx. 100 mg (determined by weight of HA counterpart); Frequency: twice daily; Duration: 26 weeks
Difference in mean change in joint pain between HA and placebo groups
As measured by the Brief Pain Inventory - Short Form (BPI-SF) questions #3-#6, #9A-G. This 14-item questionnaire was developed for use in patients with cancer that uses a scale from 0 to 10 to assess worst pain, pain severity, and pain interference over the past week. The first 8 items have to do with the severity of the pain, and the remaining 7 items ask about how the pain has affected function.
Time frame: 14 weeks
Incidence of treatment-emergent adverse events (i.e. safety and tolerability of HA)
Summary of adverse events as measured by CTCAE v4.0
Time frame: 30 weeks
Difference in mean joint symptoms between HA and placebo groups
As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Time frame: 6, 14, and 26 weeks
Difference in mean joint function between HA and placebo groups
As measured by Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH) scores. This 11-item instrument assesses physical function and symptoms in patients with musculoskeletal disorders of the upper limbs. It is a questionnaire scored from 1 to 5, with the higher score indicating worse symptoms, and there is a validated method to calculate a single Disability/Symptom Score.
Time frame: 6, 14, and 26 weeks
Difference in mean quality of sleep between HA and placebo groups
As measured by Pittsburgh Sleep Quality Index (PSQI) scores. This an 18-item instrument produces a global sleep-quality score and the following component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction.
Time frame: 6, 14, and 26 weeks
Difference in global change between HA and placebo groups
As measured by Patient's Global Impression of Change scale (PGIC) scores
Time frame: 6, 14, and 26 weeks
Difference in mean change in WOMAC subscale 1 scores between HA and placebo groups
As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) subscale 1 scores. As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Time frame: 6, 14, and 26 weeks
Difference in mean change in WOMAC subscale 2 scores between HA and placebo groups
As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) subscale 2 scores. As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Time frame: 6, 14, and 26 weeks
Difference in mean change in WOMAC subscale 3 scores between HA and placebo groups
As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) subscale 3 scores. As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Time frame: 6, 14, and 26 weeks
Time to discontinuation of second aromatase inhibitor due to AIMSS between HA and placebo groups
As measured by patient self-report of mediation compliance (medication diary) and chart review
Time frame: 26 weeks
Proportion of patients that remain on second aromatase inhibitor between HA and placebo groups
As measured by patient self-report of mediation compliance (medication diary) and chart review
Time frame: 26 weeks
Rate of 90% compliance between HA and placebo groups
As measured by patient self-report of mediation compliance (medication diary)
Time frame: 26 weeks
Mean frequency of as needed analgesia between HA and placebo groups
As measured by patient self-report of mediation compliance (medication diary)
Time frame: 6, 14, and 26 weeks
Plan to share: No
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