NCT07177820招募中不适用
Video-Guided Acupuncture Imagery Treatment in Chemotherapy-induced Peripheral Neuropathy
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility related outcomes
研究概览
简要总结
Perform a feasibility study on imagined acupuncture treatment of Chemotherapy-induced peripheral neuropathy (CIPN)
详细描述
We will perform a pilot study to assess the feasibility of Video-Guided Acupuncture Imagery Treatment (VGAIT) on CIPN symptoms in patients with stage I-III breast cancer with persistent CIPN after adjuvant chemotherapy. Participants will receive 16 sessions of VGAIT over 8 weeks remotely through the zoom. Study measures will be collected at the time of study enrollment, week 4, and week 8. The primary endpoints of the study will be 1) retention to treatment; 2) satisfaction for the intervention and 3) completion of study assessments.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age
- •have histologically confirmed stage I-III breast cancer,
- •have completed adjuvant taxane-based chemotherapy (alone or in combination), ,
- •have an Eastern Cooperative Oncology Group performance status of 0 or 1, and reported grade 1 or greater CIPN symptoms for more than 2 weeks as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
排除标准
- •concurrent chemotherapy (there were no limitations on time from the last paclitaxel administration),
- •having metastatic or recurrent disease,
- •history of preexisting peripheral neuropathy prior to chemotherapy,
- •uncontrolled seizure disorder,
- •unstable cardiac disease or myocardial infarction within 6 months prior to study entry, being pregnant or nursing, or having used acupuncture for CIPN within 6 months prior to study entry.
研究组 & 干预措施
VGAIT
Experimental
干预措施: Video-Guided Acupuncture Imagery Treatment (VGAIT) (Other)
结局指标
主要结局
Feasibility related outcomes
时间窗: 8 week
Completion, satisfaction
次要结局
- Patient Neurotoxicity Questionnaire (PNQ)(baseline, 8 week)
- Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX)(baseline, 8 week)
- Brief Pain Inventory-short form (BPI-SF)(baseline, 8 week)
- European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (QLQ-C30) instrument(baseline, 8 week)
- MGH Acupuncture Sensation Scale (MASS)(after each intervention)
- Pain Catastrophizing Scale (PCS)(baseline, 8 week)
研究者
Jian Kong
Professor
Massachusetts General Hospital
研究点 (1)
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