Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting: Randomised Double-blind Placebo-control Cross Over Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Nausea score
研究概览
简要总结
Breast cancer patient receiving AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) who has nausea score from 40/100 VAS or vomiting after the first or second cycle of chemotherapy is recruited. The patient who meets the eligibility criteria and provides informed consent is randomised to receive either Ginger capsule (500 mg) or placebo taking twice a day by mouth during the first 5 days of chemotherapy cycle. The study drug will be switched on the subsequent cycle (i.e. the patient who received Ginger capsule will receive placebo and vice versa). The primary outcome is the nausea score and vomiting during the first 5 days of each chemotherapy cycle when receiving the study drug.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed breast cancer patient
- •Received AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) and has nausea score at least 40/100 VAS or has vomiting
- •Expect to receive at least 2 further cycles of AC regimen chemotherapy
- •Provide informed consent
排除标准
- •Pregnancy or lactation
- •Has nausea or vomiting during 24 hours before chemotherapy
- •Has other causes of nausea or vomiting eg. brain metastasis, gut obstruction, hepatitis or recent abdominal or pelvic irradiation within 1 week before chemotherapy
- •Received any chemotherapy regimen other than AC regimen
- •Allergic or intolerance to ginger
研究组 & 干预措施
Ginger
Ginger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle
干预措施: Ginger (Drug)
Placebo
Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle
干预措施: Placebo (Drug)
结局指标
主要结局
Nausea score
时间窗: The first 5 days of chemotherapy cycle
次要结局
未报告次要终点