Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire
研究概览
简要总结
Chemotherapy is a cancer therapy performed on advanced cancer with quite good success, but this therapy has quite a lot of side effects. Chemotherapy induced nausea and vomiting or commonly known as CINV, is a condition of nausea and vomiting experienced by cancer patients undergoing chemotherapy, with a prevalence of around 80% of all patients undergoing chemotherapy, and 40% has the potential to become severe. This study aims to determine the efficacy of a new acupuncture modality, namely the press needle, in preventing CINV symptoms in pediatric patients with cancer undergoing chemotherapy.
详细描述
The study was conducted using a randomized controlled clinical trial (RCT) design in 64 pediatric cancer patients undergoing chemotherapy who were randomized into 2 groups, namely: (1) standard medical therapy as the control group; and (2) a combination of standard therapy with press needle acupuncture as the treatment group. The ear acupuncture points used are Shenmen and Stomach, and one body acupuncture point is PC6. Outcome measurements were carried out in the form of the RINVR questionnaire to assess the intensity of nausea and vomiting measured at 4 times: (1) 12 hours before chemotherapy; (2) 12 hours after chemotherapy; (3) 3 days after chemotherapy; (4) 7 days after chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with cancer who are undergoing chemotherapy.
- •Age 6 - 18 years.
- •Patients with platelet counts > 20,000/μL and neutrophil values > 1,000/μL.
- •Willing to follow the research.
排除标准
- •Patients with local infection in the puncture area.
- •Patients with anatomic abnormalities in the auricle.
- •Did not complete the acupuncture therapy until it was finished (three days after chemotherapy).
结局指标
主要结局
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire
时间窗: 9 days
Method instrument for assessing nausea and vomiting consisting of eight statements
次要结局
未报告次要终点
研究者
Wahyuningsih Djaali
Lecturer of Indonesia University
Indonesia University