Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Acupressure may help to reduce or prevent nausea in patients who are undergoing chemotherapy. It is not yet known whether acupressure plus standard care for nausea is more effective than standard care alone for nausea in women who are receiving chemotherapy for breast cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of acupressure in treating nausea in women who are receiving combination chemotherapy for breast cancer.
详细描述
OBJECTIVES:
- Compare nausea experience and intensity in women with breast cancer receiving one of three combination therapy regimens when treated with standard nausea care plus acupressure vs standard nausea care alone.
- Compare the quality of life, presence of anxiety, and functional status of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to chemotherapy regimen (doxorubicin and cyclophosphamide vs doxorubicin, cyclophosphamide, and fluorouracil vs doxorubicin with paclitaxel or docetaxel vs fluorouracil, epirubicin, and cyclophosphamide) and treatment setting. Patients are randomized to 1 of 3 arms.
- Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.
- Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.
- Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.
All patients complete a daily log during the second or third course of chemotherapy. Quality of life is assessed at baseline and after the last treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Acupressure
Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.
干预措施: management of therapy complications (Procedure)
Acupressure
Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.
干预措施: nausea and vomiting therapy (Procedure)
Acupressure
Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.
干预措施: acupressure therapy (Procedure)
Placebo Acupressure
Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.
干预措施: acupressure therapy (Procedure)
Placebo Acupressure
Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.
干预措施: management of therapy complications (Procedure)
Placebo Acupressure
Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.
干预措施: nausea and vomiting therapy (Procedure)
Usual Care
Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.
干预措施: management of therapy complications (Procedure)
Usual Care
Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.
干预措施: nausea and vomiting therapy (Procedure)