A Novel Therapeutic Intervention to Restore Health and Functioning in Persons With Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Accrual
研究概览
简要总结
This clinical trial studies how well whole body vibration works in improving the health and functioning of participants with chemotherapy-induced peripheral neuropathy. Peripheral neuropathy is a condition caused by exposure to chemotherapy drugs that may involve numbness/tingling and/or pain in the hands and feet, which can have adverse effects on daily life. Whole body vibration may cause weight loss and improve mobility and pain levels in cancer survivors who report symptoms of peripheral neuropathy.
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility and safety of whole body vibration (WBV) in adult cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN).
II. Determine the effect of WBV training on physical functioning in adult cancer survivors with CIPN.
III. Explore the effect of WBV training on symptom relief (neuropathy symptoms, pain, fatigue) and readiness to exercise in adult cancer survivors with CIPN.
OUTLINE: Participants are randomized to 1 of 2 groups.
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
- Single (Outcomes Assessor)
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
- •Histologically confirmed cancer stage I-IIIc (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
- •Previous chemotherapy within five years of enrollment (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
- •Presence of mild-very severe CIPN symptoms (confirmed by assessment using the Patient-Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE] criteria)
- •Age 18 years or older at enrollment (confirmed by self-report on the Health History Questionnaire)
排除标准
- •Body weight > 275 pounds (confirmed by self-report on the Health History Questionnaire)
- •A medical condition, movement or neurological disorder, or medication use that contraindicates participation in low intensity exercise and/or WBV (confirmed by self-report on the Health History Questionnaire, and by physician clearance, if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible.)
- •Presence of any known metastases (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
- •Adjuvant treatment for cancer within previous six weeks, other than hormone blocking, targeted or immunotherapy (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
研究组 & 干预措施
Usual Care (UC)
Participants randomly assigned to the UC group will serve as controls and will be tested at the same time points as the WBV group. The UC group will be asked not to change their physical activity or dietary habits across the intervention period and we will track any changes using a questionnaire.
Whole body vibration (WBV)
Participants assigned to the WBV group will participate in twice daily 10-minute WBV training sessions, 7 days a week. Each WBV session will consist of a series of timed stands on the vibration platform (Marodyne LiV). During a timed stand, participants will perform slow controlled weight shifting exercises and gentle squats. The vibration frequency will be set at 30Hz and the amplitude set at 50-200 microns, for a total body acceleration of 0.4g+/-20%.
干预措施: Whole Body Vibration (Behavioral)
结局指标
主要结局
Accrual
时间窗: Up to 12-weeks
The number of participants enrolled during the recruitment period.
Adherence
时间窗: Up to 12-weeks
Adherence = % of sessions attended and compliance = % of each session completed.
Compliance
时间窗: Up to 12-weeks
Compliance = % of each session completed.
Adverse events
时间窗: Weekly up to 12-weeks
An in-house survey will ask about adverse events (e.g., bone pain, nausea) that occur during the intervention. The number of discrete moderate and severe adverse events will be summed as a single variable.
次要结局
- Functional balance-sway amount(0, 12 weeks)
- Symptoms of chemotherapy-induced peripheral neuropathy(0, 12 weeks)
- Functional balance-sway velocity(0, 12 weeks)
- Objective physical function(0, 12 weeks)
- Functional mobility(0, 12 weeks)
- Fatigue Visual Analog Scale(Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks)
- Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale(0, 12 weeks)
- Perceived physical function(0, 12 weeks)
- Exercise readiness(1, 12 weeks)
- Functional balance-sway area(0, 12 weeks)
- Brief Pain Inventory(0, 12 weeks)
- Body mass index(0, 12 weeks)
- Pain Visual Analog Scale(Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks)
- Gait(0, 12 weeks)
研究者
Kerri Winters
Principal Investigator
OHSU Knight Cancer Institute