NCT05374876已完成不适用
Pilot Randomized Feasibility Trial Comparing Investigational Hand Therapy Intervention to Traditional Occupational Therapy Intervention to Prevent Chemotherapy-Induced Peripheral Neuropathy of the Hands in Patients Receiving Albumin Bound Paclitaxel + Gemcitabine Containing Combination Chemotherapy
HonorHealth Research Institute1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2016年5月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in Cutaneous Sensation
研究概览
简要总结
A pilot randomized feasibility trial with a blinded evaluator.
详细描述
Chemotherapy-induced peripheral neuropathy (CIPN) has a dose limiting effect which can greatly affect quality of life and often limits the amount of treatment patients can receive in treating their cancer. In the discipline of hand therapy, there is a science-based body of knowledge with effective protocols to treat neuropathies associated with injury and disease. These interventions have not been explored on patients with CIPN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with adenocarcinoma of the pancreas who will receive chemotherapy with albumin bound paclitaxel plus gemcitabine containing combination
- •Patients who have no prior evidence of peripheral neuropathy of the hands
- •Age 18 years or older
- •Able to sit for minimum of 30 minutes for hand therapy sessions
排除标准
- •Patients who have received at least one dose of chemotherapy with albumin bound paclitaxel plus gemcitabine during the past 6 months
- •Patients taking duloxetine or gabapentin
- •History of peripheral neuropathy of the hands due to chemotherapy, diabetes, or other causes
- •Inability to sit for minimum of 30 minutes
- •Documented cognitive problems limiting ability to participate in hand therapy
研究组 & 干预措施
Traditional occupational therapy intervention targeting compensatory strategies (TOT)
Other
干预措施: Traditional Occupational Therapy (TOT) (Other)
Investigational hand therapy (IHT)] intervention targeting the nervous system
Experimental
干预措施: Hand Therapy Until CIPN (Other)
结局指标
主要结局
Change in Cutaneous Sensation
时间窗: time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
measured by CTCAE Version 4
次要结局
- Change in median nerve tolerance at the right and left volar wrist(time of consent until the time of onset of CIPN of the hands or through 84 days of treatment)
- Indication of irritability of the median and ulnar nerve at the right and left wrist(time of consent until the time of onset of CIPN of the hands or through 84 days of treatment)
- Change in pressure threshold sensation(time of consent until the time of onset of CIPN of the hands or through 84 days of treatment)
- Change in peripheral nerve tolerance at the thoracic level of the right and left arm(time of consent until the time of onset of CIPN of the hands or through 84 days of treatment)
- Change in ulnar nerve tolerance at the right and left elbow(time of consent until the time of onset of CIPN of the hands or through 84 days of treatment)
- Change in pain(time of consent until the time of onset of CIPN of the hands or through 84 days of treatment)
- Change in moving touch sensation(time of consent until the time of onset of CIPN of the hands or through 84 days of treatment)
- Change in innervation density(time of consent until the time of onset of CIPN of the hands or through 84 days of treatment)
研究者
研究点 (1)
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