Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy. A Randomised Controlled Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Fatigue scale
研究概览
简要总结
Breast cancer patients report many symptoms while undergoing conventional care, including nausea/vomiting, fatigue, pain, depression and anxiety. Existing interventions to address these common side effects of treatment are limited. Patients diagnosed with cancer frequently seek complementary medicine (CAM), and there is a need to investigate potential effects of CAM therapies. This phased pilot and feasibility study has two aims:
- Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in Norway.
- Implement the treatment protocol in a pilot study to evaluate outcome measures, effect sizes and acceptability of acupuncture care delivered alongside conventional care.
Study results will support the design of future research; including a Phase III randomised controlled trial.
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
- Single (Outcomes Assessor)
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
- •Females, 18 years or older with early stage breast cancer, no previous chemotherapy and no metastatic disease
排除标准
- •Needle phobia, use of anticoagulant drugs, inability to comply with study regimen
研究组 & 干预措施
acupuncture therapy
Breast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy
干预措施: Acupuncture therapy (Procedure)
Usual care
Control group (usual care) receives standard chemotherapy alone
干预措施: Acupuncture therapy (Procedure)
结局指标
主要结局
Fatigue scale
时间窗: Weeks 16 and 29
次要结局
- Hospital anxiety and depression scale (HADS)(Weeks 16, 19 and 29)
- Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw(Weeks 16, 19 and 29)