Randomized Study Assessing the Benefits of Foot Reflexology in Patients With Gastrointestinal or Thoracic Cancer With Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Evaluation of nausea and vomiting
研究概览
简要总结
Chemotherapy with platinum salts is very emetic. The aim of this study is to evaluate the benefits of foot reflexology in nausea and vomiting induced by platinum salts-based chemotherapy in patients with thoracic or digestive tumors.
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
- 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
- •Patient with a thoracic or digestive cancer with indication of management with platinum salts-based chemotherapy
- •Good performance status of (ECOG 0-2)
- •More than 18 years old
- •Ability to complete the questionnaires (comprehension oral and written French language) and to carry out the required exercises.
- •Patient affiliated to Social Security or equivalent
- •Informed consent signed
排除标准
- •Phlebitis
- •Cellar syndrome
- •Weight loss> 5% in 3 months
- •Uncontrolled pain
- •Patients under morphine and derivatives
- •Brain metastases
- •Patient benefiting from foot reflexology outside the study
- •Patient under guardianship or curatorship or deprived of his rights
研究组 & 干预措施
foot reflexology
patients WITH foot reflexology session during chemotherapy treatments
干预措施: INTERVIONNAL (Behavioral)
platinum-based treatment
Patients WITHOUT ANY foot reflexology session during chemotherapy treatments
干预措施: CONTROL (Other)
结局指标
主要结局
Evaluation of nausea and vomiting
时间窗: 6 hours
The relative change in VAS\* associated with nausea and vomiting will be evaluated between T1 (measured at least 2 hours after the start of chemotherapy injection) and T2 (measured at least 6 hours after the start of injection of the drug chemotherapy). \*VAS : from 0 to 10 ; 0 is no nausea or vomiting and 10 is insufferable nausea or vomiting
次要结局
- Nausea and vomiting between each chemotherapy(Day 0, between day 14 and day 21, between day 28 and day 42, between day 42 and day 63.)
- Quality of life(Between day 0 and day 78)
- Anxiety(Between day 0 and day 78)
- Body image(Day 0)