Single Center, Placebo-Controlled Trial of Oral High-Molecular Weight Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Difference in mean change in joint pain between HA and placebo groups
研究概览
简要总结
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.
详细描述
Primary Objective To determine whether oral HA will prevent AI-induced arthralgias and preserve physical function.
Secondary Objectives
- To explore whether oral HA will have an acceptable safety and tolerability profile.
- To determine whether oral HA will prevent other AI associated symptoms as assessed by patient reported outcomes (PRO's).
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
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.
干预措施: Placebo (Other)
Hyaluronic Acid
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.
干预措施: Hyaluronic Acid (HA) (Drug)
结局指标
主要结局
Difference in mean change in joint pain between HA and placebo groups
时间窗: 14 weeks
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.
次要结局
- Difference in mean quality of sleep between HA and placebo groups(6, 14, and 26 weeks)
- Difference in mean change in WOMAC subscale 3 scores between HA and placebo groups(6, 14, and 26 weeks)
- Proportion of patients that remain on second aromatase inhibitor between HA and placebo groups(26 weeks)
- Mean frequency of as needed analgesia between HA and placebo groups(6, 14, and 26 weeks)
- Difference in mean change in WOMAC subscale 2 scores between HA and placebo groups(6, 14, and 26 weeks)
- Rate of 90% compliance between HA and placebo groups(26 weeks)
- Difference in global change between HA and placebo groups(6, 14, and 26 weeks)
- Difference in mean change in WOMAC subscale 1 scores between HA and placebo groups(6, 14, and 26 weeks)
- Incidence of treatment-emergent adverse events (i.e. safety and tolerability of HA)(30 weeks)
- Difference in mean joint symptoms between HA and placebo groups(6, 14, and 26 weeks)
- Difference in mean joint function between HA and placebo groups(6, 14, and 26 weeks)
- Time to discontinuation of second aromatase inhibitor due to AIMSS between HA and placebo groups(26 weeks)
研究者
Erin Newton
Assistant Professor of Clinical Medicine
Indiana University School of Medicine