Phase 2 Study of Aromatase Inhibitor-Associated Musculoskeletal Symptom Prevention With Resistant Potato Starch (AIMSS-RPS)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients who took at least 70% of resistant potato starch (RPS) doses per protocol
研究概览
简要总结
This phase II trial tests the safety and effectiveness of a dietary supplement called resistant potato starch for reducing musculoskeletal symptoms in patients with stage 0-III breast cancer or who are at high risk for breast cancer and are planning to receive treatment with an aromatase inhibitor. Aromatase inhibitors are a type of drug commonly used for the treatment or prevention of breast cancer. Many people who receive aromatase inhibitors experience musculoskeletal symptoms (symptoms relating to bones and muscles, such as joint pain or stiffness). Research has shown there may be an association between reduced levels of beneficial gut bacteria and the development of aromatase inhibitor-associated musculoskeletal symptoms. Resistant potato starch is a plant-based low-digestible carbohydrate that has the potential to promote the growth of beneficial gut bacteria. Taking resistant potato starch while receiving aromatase inhibitor therapy may reduce musculoskeletal symptoms in patients with stage 0-III breast cancer or individuals at high risk of developing breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient who is planning to start standard-of-care AI therapy and receive treatment for at least 24 weeks. Can be planning to take AI therapy for stage 0-3 breast cancer or because they are at high risk of developing breast cancer. Concurrent gonadotropin-releasing hormone antagonist (GnRHa) therapy, anti-osteoclast therapy, anti-HER2 therapy, ribociclib, and/or PARP inhibitor are permitted
- •Average joint pain 0-6 on a 0-10 scale during the 7 days prior to study enrollment
- •Able to take oral medication
- •Able to read and understand English
- •Aware of the nature of her diagnosis, understands study requirement, and able to sign an informed consent form
排除标准
- •Distant metastatic breast cancer
- •Current or planned use of abemaciclib during study participation
- •Current or planned use of chemotherapy or immunotherapy during study participation
- •Pregnant or breast feeding, or planning to become pregnant during study participation
- •Known active inflammatory bowel disease
- •History of colectomy and/or gastric bypass
- •Prior AI therapy except in the context of fertility treatment
- •Planned use of prebiotics during study participation
- •Use of estrogen supplementation other than vaginal estrogen
- •Receipt of another investigational agent concurrent with participation in this trial
研究组 & 干预措施
Supportive Care (RPS)
Participants receive RPS PO QD for 24 weeks in the absence of unacceptable toxicity.
干预措施: Starch, Potato (Drug)
结局指标
主要结局
Proportion of patients who took at least 70% of resistant potato starch (RPS) doses per protocol
时间窗: Up to 24 weeks
Will be assessed using patient self-report. The study will be deemed feasible if at least 60% of patients take at least 70% of protocol-directed doses of RPS, as assessed on the treatment logs. Will be evaluated with a 95% confidence interval.
次要结局
- Incidence of adverse events(Up to 24 weeks)
- Relative abundance of Bifidobacteria(At baseline and 12 weeks)
- Proportion of patients who discontinue initially prescribed aromatase inhibitor medication due to toxicity(Up to 24 weeks)