A Randomized Phase III Clinical Trial of Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 227
- 试验地点
- 14
- 主要终点
- measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga
研究概览
简要总结
The purpose of this study is to test whether yoga can reduce nerve pain caused by cancer treatment (chemotherapy-induced peripheral neuropathy, or CIPN). Participants will take one of three approaches:
- Yoga classes
- Educational sessions on the causes and impacts of CIPN, how yoga may help with CIPN, and how different therapies may help with CIPN
- Usual care with standard-of-care medications for CIPN
The researchers will compare how these different approaches affect participants' balance, their risk of falls, and their quality of life. This study will also measure how much yoga can help the reduced sense of touch caused by CIPN.
The functional assessments Timed Up and Go (TUG) and Chair to Stand (CTS) can be safely completed either virtually and in-person and will be mandatory for all patients. The functional assessment Functional Reach Test (FRT) and Quantitative Sensory Testing (QST) assessments that can only be completed in-person are optional at these time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The PI and investigators will be blinded to the patient's group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-proficient men and women aged ≥18 years
- •Free of oncologic disease or or stable disease by clinical examination and history
- •Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment
- •Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- •Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week
- •On a stable regimen (no change in three months) if taking anti-neuropathy or other pain medications and not taking acetyl-L-carnitine
- •Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period
- •Willing to adhere to all study-related procedures, including randomization to one of the three arms
- •Patient answers "Yes" to at least one factor in the question: "Do you think your balance, gait, posture, alignment, or flexibility has been affected by your experience of CIPN?"
排除标准
- •Patients who have received physical therapy or practiced yoga for CIPN in the past 3 months. As patients who have received physical therapy or practiced yoga in this time period may already be experiencing its benefits, we will exclude such patients.
研究组 & 干预措施
Yoga
Participants will receive twice weekly yoga over the course of 8 weeks.
干预措施: Yoga (Other)
Education control (EC)
Participants will receive twice weekly education over the course of 8 weeks
干预措施: Education control (Other)
Usual care (UC)
8 weeks of usual care
干预措施: Usual care (Other)
结局指标
主要结局
measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga
时间窗: up to 24 weeks
as measured by the Brief Pain Inventory-Short Form (BPI-SF) compared to EC and UC arms at week 8 response choices of 0 ("no pain") to 10 ("pain as bad as you can imagine").
次要结局
未报告次要终点
研究者
Ting Bao, MD
Principal Investigator
Dana-Farber Cancer Institute