A Phase II Study of Acupuncture for the Treatment of Cancer Related Fatigue in Children and Adolescents With Central Nervous System Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- cancer-related fatigue
研究概览
简要总结
Cancer-related fatigue occurs in both adult and pediatric patients undergoing chemotherapy and/or radiation. Recently, methods to measure fatigue have improved - however, no non-medication interventions have been studied. Ameliorating fatigue may result in an improved quality of life for patients. Acupuncture is a safe and well-tolerated procedure and has been used for many indications in pediatric patients. Adult studies have suggested improvement in cancer-related fatigue after acupuncture in adults. In this trial, we propose using acupuncture for the treatment in cancer-related fatigue in children and adolescents with central nervous system tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients who are ≥ 8 year of age and ≤ 21 years of age who are undergoing chemotherapy and/or radiation therapy for the treatment of any primary or recurrent central nervous system tumor (regardless of diagnosis or disease stage, whether it is malignant or benign, and in any location) at Children's Memorial Hospital.
- •Patients who recently completed therapy (within 60 days of enrollment) will also be eligible. Patients must have a minimum baseline fatigue score of 15 on the pedsFACIT-F scale (Range 0-44). This is not a standard assessment for required clinical care and will only be administered by a research assistant to any patient after consent has been obtained. The assessment will be done during a routine clinic visit.
- •For patients receiving cytotoxic chemotherapy with a history of myelosuppression or radiation, a hemoglobin concentration of >8 g/dL measured within 10 days of enrollment and a platelet count of > 30,000 within 5 days of enrollment is required.
- •Patients must also be able to read and understand English and read a computer screen.
- •Patients with no known contraindications to acupuncture therapy.
- •Patients who are able to attend all scheduled visits for acupuncture.
- •Patients must have a Karnofsky Performance Score of ≥ 50% or a Lansky Performance Score of ≥
- •Patients who have provided informed consent for the research study (parental consent for patients < 18 years of age). Patients between 12 years and 18 years of age must provide assent in additional to parental consents.
排除标准
- •Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue.
- •Patients who have received acupuncture in the previous six weeks.
- •Patients with a life expectancy < 3 months.
- •Patients who are pregnant or lactating.
- •Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.
结局指标
主要结局
cancer-related fatigue
时间窗: Participants will be on-study for up to 14 weeks. . No follow-up will be required after the completion of the study.
次要结局
未报告次要终点
研究者
Rishi Lulla
Prinicipal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago