Effectiveness of Combined Laserpuncture And Antiemetic Therapy on the Rhodes Index of Nausea, Vomiting and Reatching (RINVR) Scores in Adolescent Cancer Patients Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- Rhodes Index nausea, vomiting and Reatching Score (RINVR)
研究概览
简要总结
Chemotherapy is a common treatment for treating cancer. Chemotherapy induced nausea and vomiting (CINV) is nausea and vomiting that occurs after chemotherapy. Complete protection of standard antiemetic drugs against CINV symptoms in children and adolescents receiving moderately and strongly emetogenic chemotherapy drugs was less than 50%.
The side effects of chemotherapy in the form of CINV are so unpleasant that chemotherapy causes extreme anxiety and stress. The psychological characteristics of adolescents who have a greater perception of the changes that occur cause more frequent anxiety which can increase the risk of CINV.
Acupuncture with laserpuncture modality is a non-pharmacological therapy that has a good effect on CINV symptoms in adolescents. This research was conducted for the first time in Brazil in 2019, while in Indonesia there has never been any research on this matter. So it is hoped that this research will be the first research in Indonesia to prove that the effect of laserpuncture plays a role in CINV symptoms in adolescents and can be an additional treatment in standard therapy for CINV problems in adolescents.
详细描述
This is a clinical trial study to evaluate and compare the effects of laserpuncture and sham laserpuncture as a therapy for Chemotherapy induced nausea and vomiting (CINV) . The subjects are 58 males/female and will be randomly assigned to 2 groups: (1) laserpunctur and (2) Sham laserpuncture. The outcome will be assessed before treatment (baseline), in chemotherapy procedure and 3 days after chemotherapy. Patients and the outcome assessors will be blinded to the group allocation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent cancer patients aged 10 - 18 years
- •Patients undergoing chemotherapy with moderate and/or strong emetogenic chemotherapy drugs
- •Patients with CINV and/or at risk of CINV
- •Willing to take part in research until completion
- •The patient has not received acupuncture therapy in the last 1 week
排除标准
- •Patients with cancerous lesions or ulcers at the location of the acupuncture points to be selected
- •Patients with digestive tract organ malignancies with complaints of nausea and vomiting before chemotherapy
- •Patients with unstable hemodynamic conditions
结局指标
主要结局
Rhodes Index nausea, vomiting and Reatching Score (RINVR)
时间窗: before chemotherapy, in chemotherapy procedure, 3 days after chemotherapy
Score for measuring nausea, vomiting and reatching after chemotherapy. minimum score is 0 and maximum score is 32
次要结局
未报告次要终点
研究者
Ramadia Yunita
doctor
Indonesia University