A Phase II Randomized Interventional Pilot Study for Colon Cancer Patients Receiving Oxaliplatin: Benefits of Cryotherapy in Prevention of Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Proportion of Participants with Peripheral Neuropathy at Visit 2
研究概览
简要总结
The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy.
详细描述
Peripheral neuropathy often manifests as numbness and tingling in the hands and feet, which may be detrimental to the patients' overall safety and quality of life, thereby causing them to stop or delay treatment. Everyday tasks such as walking, buttoning a shirt, or tying shoes can become challenging. Select chemotherapy agents are known to cause significant peripheral neuropathy. Studies have been performed demonstrating efficacy of using cryotherapy, which causes vasoconstriction, to targeted areas of the body, in relation to paclitaxel. These studies have shown drastic differences between those who receive cryotherapy during treatment and those who do not. There are few studies on the use of cryotherapy in the prevention of peripheral neuropathy with the use of oxaliplatin, which will be undertaken in this study.
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
- 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
- •Over the age of 18 years
- •Willingness to participate in research
- •Diagnosed with stage III colon cancer
- •Chemotherapy naïve
- •Planning to initiate Capecitabine + Oxaliplatin (CAPOX) chemotherapy regimen as part of standard of care.
排除标准
- •Pre-existing peripheral neuropathy
- •Pre-existing diabetes
- •Raynaud's disease
- •Metabolic syndrome, including: Hypertension; Hypercholesterolemia; and Obesity (BSA > 2)
- •Upper extremity amputees
- •Specific autoimmune diseases: Guillain-Barre; Lupus; Rheumatoid arthritis; and Sjogren's syndrome
研究组 & 干预措施
Cryotherapy
Patients receiving oxaliplatin who are randomized to the Interventional (Cryotherapy) Arm will wear a pair of gloves that has removable ice packs throughout their treatment, starting 15 minutes before and ending 15 minutes after completion of oxaliplatin. These ice packs will be replaced every 30 minutes. The total wearing time of the cryotherapy will be approximately 2 hours.
干预措施: Cryotherapy Gloves (Device)
Control
Patients receiving oxaliplatin who are randomized to the Control Arm will not receive the gloves with removable ice packs throughout their treatment.
结局指标
主要结局
Proportion of Participants with Peripheral Neuropathy at Visit 2
时间窗: Visit 2 (Day 1)
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Proportion of Participants with Peripheral Neuropathy at Visit 3
时间窗: Visit 3 (Day 21)
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Proportion of Participants with Peripheral Neuropathy at Visit 5
时间窗: Visit 5 (Day 63)
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Proportion of Participants with Peripheral Neuropathy at Visit 4
时间窗: Visit 4 (Day 42)
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
次要结局
未报告次要终点