Acupuncture as add-on to GCS-F Treatment for Reducing Febrile Neutropenia-related Hospitalization in Patients Undergoing Doxorubicin-based Treatment for Sarcoma: a Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Duration of chemotherapy-induced febrile neutropenia-related hospitalization
研究概览
简要总结
Chemotherapy-induced febrile neutropenia (CIFN) is a dangerous complication of many chemotherapy drugs, with current treatment with granulocyte colony-stimulating factors (G-CSFs) accompanied by adverse effects, primarily muscle and bone pain. Adult patients with sarcoma treated with doxorubicin-based chemotherapy have a high risk (>40%) for developing CIFN. Acupuncture has been shown to have a potentially myelo-protective effect on bone marrow during chemotherapy, though its effect on the incidence of CIFN-related hospitalization has yet to be examined. In the proposed study, patients with sarcoma will be randomly allocated (in a ratio of 1:1) to Group A, receiving acupuncture during cycles 1, 3, and 5; or Group B, during cycles 2, 4, and 6, with the study oncologist blinded regarding allocation. Acupuncture will be administered on the first day (d1) and the 8th day (d8) of the chemotherapy cycles, with press-tack needles on d1 to d8, and patients will be taught to self-treat with acupressure from d8 to the next cycle. The incidence and duration of hospitalization due to CIFN will be examined, as will adherence to the chemotherapy regimen; G-CSF-related pain; and other outcomes using 3 quality-of-life-focused questionnaires. The study findings will have important implications regarding the role of acupuncture in the treatment of patients treated with chemotherapy drugs with a high risk for CIFN, such as those used in the treatment of sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
he treating oncologist will be blinded as to the patient's allocation and study intervention during each cycle of chemotherapy.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65 years
- •diagnosed with sarcoma of any stage
- •scheduled for doxorubicin-based chemotherapy
- •function ECOG status score of 0-1
排除标准
- •not fulfilling all inclusion criteria
- •unwilling or unable to provide written informed consent for study participation
结局指标
主要结局
Duration of chemotherapy-induced febrile neutropenia-related hospitalization
时间窗: 3 weeks
Incidence of chemotherapy-induced febrile neutropenia-related hospitalization
时间窗: 3 weeks
次要结局
- Quality of life-related outcomes: Quantitative Assessment(3 weeks)
- Quality of life-related outcomes: Qualitative Assessment(3 weeks)
- Relative Dose Intensity of Chemotherapy Regimen(3 weeks)
- G-CSF-related muscle and bone pain(3 wseks)
- Adverse effects of study intervention(3 weeks)
研究者
Noah Samuels
Director, Center for Integrative Complementary Medicine
Shaare Zedek Medical Center
