A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion
研究概览
简要总结
RATIONALE: Electroacupuncture may help to reduce or prevent delayed nausea and vomiting in patients treated with chemotherapy.
PURPOSE: This randomized clinical trial is studying the effectiveness of electroacupuncture in treating delayed nausea and vomiting in patients who are receiving chemotherapy for newly diagnosed childhood sarcoma, neuroblastoma, nasopharyngeal cancer, germ cell tumors, or Hodgkin lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of electroacupuncture, in terms of reducing acute and delayed chemotherapy-induced nausea, in patients with newly diagnosed pediatric sarcoma, neuroblastoma, nasopharyngeal carcinoma, or germ cell tumors.
Secondary
- Determine the efficacy of this therapy, in terms of reducing delayed chemotherapy-induced emesis, in these patients.
- Determine the efficacy of this therapy, in terms of altering salivary cortisol levels and fasting serum glucose and insulin levels as stress parameters, in these patients.
- Determine the efficacy of this therapy, in terms of improving the quality of life, in these patients.
- Determine the efficacy of this therapy, in terms of reducing acute nausea and emesis, in these patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 5 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Newly diagnosed malignancy of 1 of the following types:
- •Pediatric sarcoma
- •Neuroblastoma
- •Nasopharyngeal carcinoma
- •Germ cell tumor
- •Hodgkin lymphoma
- •Meets 1 of the following criteria:
- •Eligible for Children's Oncology Group (COG) protocol for sarcoma, neuroblastoma, or germ cell tumor
- •Eligible for NCI Pediatric Oncology Branch (POB) protocol for sarcoma
- •Following COG-approved standard treatment regimen for sarcoma, neuroblastoma, nasopharyngeal carcinoma, or germ cell tumor
- •Enrolled on the POB natural history protocol 98-C-0037
- •Planned treatment, according to COG or POB protocols, that includes a cisplatin- and/or doxorubicin-containing regimen for sarcoma, neuroblastoma, nasopharyngeal carcinoma, germ cell tumor, or Hodgkin lymphoma OR either a cyclophosphamide/ifosfamide-doxorubicin-containing or cyclophosphamide/dactinomycin-containing regimen for rhabdomyosarcoma
- •No clinical or radiographic signs of spinal cord compression
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count greater than 50,000/mm^3 (transfusion independent)
- •No clotting disorders, including hemophilia
- •PT and PTT normal (within 10% of institution's upper limit of normal)
- •Not specified
- •Not pregnant
- •No casting of 1 or more extremities
- •No other condition that would preclude access to acupuncture points
- •No cognitive impairment
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •No prior systemic chemotherapy
- •Endocrine therapy:
- •More than 4 weeks since prior glucocorticoid therapy
- •No concurrent glucocorticoid therapy
- •Radiotherapy:
- •Not specified
- •Not specified
- •No prior acupuncture
- •No concurrent anticoagulants
排除标准
- 未提供
研究组 & 干预措施
Arm I (alternative medicine procedure)
Patients undergo electroacupuncture therapy to specific acupuncture points on the arms and legs over 25 minutes twice daily on days 1 and 2 and then once daily on days 3-7 during week 1 of chemotherapy course 1 (9 acupuncture treatments total).
干预措施: electroacupuncture therapy (Procedure)
Arm I (alternative medicine procedure)
Patients undergo electroacupuncture therapy to specific acupuncture points on the arms and legs over 25 minutes twice daily on days 1 and 2 and then once daily on days 3-7 during week 1 of chemotherapy course 1 (9 acupuncture treatments total).
干预措施: quality-of-life assessment (Procedure)
Arm II (alternative medicine procedure)
Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.
干预措施: sham intervention (Procedure)
Arm II (alternative medicine procedure)
Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion
时间窗: 7 days
A two-sample t-test will be used. In the event the data are not normally distributed in one or both arms, a Wilcoxon rank sum test will be used.
次要结局
- Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion(Day 8)
- Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion(Day 1)