Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of episodes of vomiting
研究概览
简要总结
This randomized pilot clinical trial studies giving acupuncture in reducing nausea and vomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether transcutaneous acupuncture point stimulation (TAPS) at P6 as an adjuvant treatment to standard antiemetic therapy reduces acute chemotherapy induced nausea and vomiting as compared to sham acupuncture point stimulation in children undergoing their first round of highly or moderately emetogenic chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy.
ARM II: Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a planned admission for at least 24 hours for highly emetogenic or moderately emetogenic chemotherapy at Lucile Packard Children's Hospital or Packard El Camino.
- •Planned to undergo at least 2 more cycles of chemotherapy.
- •Can include but not limited to: children with high risk ALL, AML, Ewing's Sarcoma, Osteosarcoma
- •History of vomiting with prior cycles of chemotherapy (2 episodes of emesis at minimum) despite use of conventional antiemetic medications.
- •Parent must be able to understand and willing to sign written informed consent document.
排除标准
- •Prior knowledge of acupuncture or experience with acupuncture or acupressure.
- •There will be no restrictions regarding use of other Investigational Agents.
- •Comorbid Diseases:
- •Diagnosis of any cardiac condition (cardiomyopathy, arrhythmia, pacemaker placement).
- •Any diagnosis requiring pediatric intensive care unit admission.
- •Patients with brain tumor, brain metastasis (these patients often require radiation and surgery in addition to chemotherapy which may confound the results)
- •Concomitant radiation therapy during current chemotherapy cycle.
- •Developmental delay patients with allergy to tape or leads will be excluded from the study.
- •Pregnant patients will be excluded from the study.
- •Cancer survivors will not be excluded from the study as long as they are undergoing chemotherapy treatment for their current cancer therapy.
- •HIV-positive patients will not be excluded.
结局指标
主要结局
Number of episodes of vomiting
时间窗: During the first 24 hours of chemotherapy
Severity of nausea as recorded on the visual analogue scale (VAS)
时间窗: During the first 24 hours of chemotherapy
Measured as a continuous variable for the mean episodes of emesis. The mean VAS nausea score will also be measured as a continuous variable. Measured using the Multinational Association of Supportive Care in Cancer (MASCC) antiemesis tool.
次要结局
- Number of as needed (PRN) antiemetic medications needed(After the first 24 hours of chemotherapy)