Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- number of sessions performed
研究概览
简要总结
The management of colorectal cancer often requires oxaliplatin-based chemotherapy, either as part of curative treatment plans or exclusively in palliative situations. Oxaliplatin therefore plays a key role in the management of colorectal cancer. In addition to its digestive and hematological toxicity, oxaliplatin frequently induces chronic, often limiting, sensitive peripheral neuropathy.
Only early discontinuation of oxaliplatin can limit the risk of clinically limiting neurotoxicity (grade ≥ 3).
In oncology, managing the side-effects of treatment is an essential objective of supportive care, and is open to a variety of complementary medicines, including reflexology. This technique, derived from traditional Chinese medicine, involves stimulating reflex points on the arch of the foot.
详细描述
This first monocentric, prospective pilot study is designed to evaluate if the intervention is feasible in routine clinical practice for patients initiating bimonthly oxaliplatin chemotherapy for colorectal cancer. It will also provide initial estimates of the parameters needed to measure efficacy and impact on patient quality of life.
Patients will receive a reflexology session with each cycle of chemotherapy, and will be assessed during all the treatment period.
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
- •Age>18 years treated for colorectal cancer in Digestive Oncology service Rangueil hospital
- •Initiation of intravenous oxaliplatin chemotherapy at 85 mg/m² on a bimonthly schedule.
- •Ability to understand and answer a self-questionnaire.
- •Life expectancy egal or over 12 weeks
- •Signed informed consent form
排除标准
- •Pre-existing motor and/or sensitive neuropathy.
- •Reflexology treatment within the last 6 months.
- •Contraindication to reflexology: venous thrombosis, trauma, wound or metastasis of the foot.
- •Patient covered by a legal protection scheme.
结局指标
主要结局
number of sessions performed
时间窗: 6 months
at least 50% of patients included and realized at least 70% of reflexology sessions over the 6-month treatment.
次要结局
- concordance of peripheral neuropathy evaluation(every month until 6 months)