IIT2019-07-ASHER-QIGONG: A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Objective Modified Total Neuropathy Scale (mTNS) score
研究概览
简要总结
This pilot study will include up to 25 patients with cancer experiencing chemotherapy-induced peripheral neuropathy. Patients enrolled in the study will participate in a 10-week QiGong for Chemotherapy-Induced Neuropathy program. Patients will be evaluated before and after their program participation. Within 2 weeks before the program start date, patients will be administered an objective neuropathy assessment by a physician or nurse, and will complete questionnaires assessing chemotherapy-induced peripheral neuropathy, perceived cognitive functioning, quality of life, and cancer-related symptoms. Patients will repeat these assessments at the end of the last QiGong class and will be asked to provide feedback on the QiGong program as a whole. Self-report questionnaires will also be repeated one week after the last class.
Total duration of subject participation will be 11-13 weeks. Total duration of the study is expected to be approximately 9 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cancer, stage 1-
- •Completed taxane- or platinum-based chemotherapy at least three months (90 days) ago but within 24 months of signing consent. Current use of anti-estrogen therapy, Herceptin, or PARP inhibitors is okay.
- •Experiencing at least grade 1 peripheral sensory neuropathy, peripheral motor neuropathy, or dysesthesias based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 (NCI CTCAE v4.0).
- •Age ≥ 18 years.
- •Concomitant use of analgesics is permitted if the dose has been stable for at least 2 weeks prior to study enrollment (no new analgesics have been added, discontinued, or changed in the 2 weeks prior to study enrollment).
- •Reasonable functional stability as assessed by the evaluating physician.
- •Must be able to understand and communicate proficiently in English.
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
排除标准
- •Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, brain injury, or stroke, as assessed by the treating physician.
- •Medical history of neuropathy from any type of nerve compression (e.g., carpal tunnel or tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy, leptomeningeal carcinomatosis), as assessed by the treating physician.
- •Neuropathy related to abnormal TSH or B12 levels as assessed by treating physician
- •Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, or major eating disorder, as assessed by the treating physician.
- •Severe personality disorder or psychiatric disorder that would interfere with participation in a QiGong program, as assessed by the evaluating physician.
- •Currently participating in another QiGong or Tai Chi program.
结局指标
主要结局
Objective Modified Total Neuropathy Scale (mTNS) score
时间窗: 10 weeks
Change in the Modified Total Neuropathy Scale (mTNS) score from Baseline to T1 (last day of class)
Subjective Neurotoxicity Subscale score
时间窗: 11 weeks
Change in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up).
次要结局
- Perceived cognitive functioning(11 weeks)
- Patient Interest(1 week)
- Attendance(10 weeks)
- Patient Evaluation of QiGong Program(1 day)
- Retention(10 weeks)
- Impact on symptom experience(11 weeks)
- Physical Well-Being(11 weeks)
- Social/Family Well-Being(11 weeks)
- Emotional Well-Being(11 weeks)
- Functional Well-Being(11 weeks)
研究者
Arash Asher, MD
Director, Cancer Rehabilitation & Survivorship
Cedars-Sinai Medical Center