Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Pain intensity during the procedure
研究概览
简要总结
To evaluate the feasibility of an acupuncture protocol in the prevention of late diarrhea due to irinotecan in pediatric patients with solid tumors, a pre-post pilot study will be conducted.
Pre-post pilot study non-randomized, open label, single arm study. There will be a single study group that will be used at the same time as your own control. The intervention will take place for approximately one year.
详细描述
Pre-post pilot study non-randomized, open label, single arm study.
The objective of this pilot study is to demonstrate that cancer acupuncture pediatric treatment is a safe and feasible treatment in the prevention of late-onset diarrhea related to with irinotecan.
This pilot study will include patients between 0 and 18 years of age with a solid tumor (nephroblastoma, neuroblastoma, central nervous system tumors and rhabdomyosarcoma) receiving their first cycle of irinotecan, in our center, at 50 mg/m2/intravenous dose daily for five days (cumulative dose weekly = 250 mg/m2) and who do not receive concomitant abdominal radiotherapy. Acupuncture will be applied as a complementary treatment along with the usual regimen of prophylaxis and treatment of late diarrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 0 to 18 years old with solid tumors who start treatment in our center with irinotecan at 50 mg/m2/intravenous dose in day hospital.
- •Blood tests prior to the start of the appropriate chemotherapy cycle to receive acupuncture with continuous stimulation needle insertion: neutrophils greater or equal to 1000 cells/mm3 and platelets greater than or equal to 50,000 cells/mm
- •Signature of informed consent by parents in the case of children under 12 years of age and assent of the minor.
- •Signature of informed consent in the case of those over 12 years of age
排除标准
- •Participate in a clinical trial that is developed in the Pediatric Oncology Area of the Hospital Sant Joan de Deu where acupuncture intervention is not permitted.
- •Have received acupuncture treatment in the last ten days.
- •Receive concomitant abdominal radiotherapy.
- •Have diarrhea on day 1 of the cycle
研究组 & 干预措施
Experimental
Pre-Post feasibility treatment On the first cycle of irinotecan, the patient does not receive any intervention, we only collect data. This is the control cycle.
There will be a single study group that will be used at the same time as your own control. On the second cycle of irinotecan, the patient receives acupuncture. There will be a single study group that will be used at the same time as your own control.
干预措施: Acupuncture (Other)
结局指标
主要结局
Pain intensity during the procedure
时间窗: Day 5
Evaluation of pain intensity during the insertion procedure of the indwelling needles. The scales will be used: crying scale (0-8) (\<3 years), Wong-Baker scale of faces for cooperative children (0-10) (\>3 years) and numerical scale (0-10) for collaborating children (\>6 years). Higher scores mean a worse result.
次要结局
- Nausea(Day 14)
- Vomiting(Day 14)
- Pain intensity during the intervention(Day 9)
- Prophylactic regimen of cefixime(Day 1)
- Determination of the UGT1A1 polymorphism(Day 1)
- Side effects(Day 9)
- Degree of severity of diarrhea(Day 14)
- Satisfaction degree(Day 15)
- Dose of antiemetic drugs (ondasentron)(Day 14)
- Dose of antidiarrheal drugs(Day 14)
- Abdominal pain treatment-related(Day 14)