Acupuncture for Joint Symptoms in Patients With Breast Cancer: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory
研究概览
简要总结
Joint symptoms including stiffness, local pain and aches are common adverse reactions among breast cancer (BC) patients undergoing hormone treatments, while effective interventions for managing such symptoms have not been well explored so far. Acupuncture can be a promising approach to controlling joint symptoms in BC patients but current research evidence generated from several small-scale clinical studies have not been robust enough to support the use of acupuncture for cancer symptom management in routine practice.
The overall aim of the research project is to examine the effectiveness of a 6-week acupuncture protocol for the management of joint symptoms in Chinese female BC patients who are currently undergoing hormone treatments following the completion of taxane-based chemotherapy. Given the lack of available data regarding the prevalence of joint symptoms in BC patients in mainland China, a large cross-sectional survey will also be performed to examine the incidence of joint symptoms among Chinese BC patients in mainland China and the impact of joint symptoms on patients' quality of life.
详细描述
A three-group trial design is proposed, with an experimental group receiving true acupuncture at specific acupuncture points, a sham control group receiving sham acupuncture at non-acupuncture Acupoints with superficial needling, both in addition to routine methods of care, and a group receiving usual care only.
Participants and Settings BC patients who have completed taxane-based chemotherapy and are currently receiving hormone treatments with the experience of joint pain will be the targeted study population. The study will take place in the Southwest Medical University Hospital, a large medical centre in Sichuan, China.
Sample Size 55 per group (165 in total).
The Intervention Protocol
- True Acupuncture Protocol will be used in the True Acupuncture Group (Experimental Group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BC patients with a confirmed diagnosis of hormone receptor-positive BC at the stage of I, II or IIIa;
- •Patients who have completed taxane-based chemotherapy and are currently undergoing hormone treatments for at least three months;
- •Patients indicate ongoing joint symptoms, including joint pain and/or stiffness, at one or more sites of body;
- •Patients started to experience the joint symptoms after the commencement of the hormone treatments;
- •Patients indicate the intensity of their worst pain during the past seven days of greater than 4 points at a 0-10 NRS scale where 0 represents no pain and 10 indicates most severe pain;
- •Patients have at least a primary school education and are able to communicate in Chinese Mandarin or Sichuanese; and
- •Patients agree to participate in the trial and are willing to give written informed consent.
排除标准
- •Patients who had needle phobia and a low count of platelet of less than 50,000;
- •Patients with conditions which are not appropriate for acupuncture including pregnancy, bleeding disorders, local or systematic inflammation, and other neuropathic and/or metabolic problems of the joints;
- •Patients who had received joint surgery or had bone fracture during the past six months;
- •Patients who had received any types of acupoint stimulation (e.g. body acupuncture or acupressure and auricular therapy) during the past six months; and
- •Patients are currently treated with narcotic analgesia or steroids.
结局指标
主要结局
Brief Pain Inventory
时间窗: 6-week assessment
Pain assessment measuring intensity of pain and impact of pain on daily functions. All items on a 0-10 numerical rating scale. Higher scores indicate worse pain and worse impact in daily lives.
次要结局
- Manchester Foot Pain Disability Questionnaire(20-week assessment)
- Brief Pain Inventory(20 weeks assessment)
- Michigan Hand Outcomes Questionnaire(20-week assessment)
- Western Ontario & McMaster Universities Osteoarthritis Index(20-week assessment)
- Arthritis Impact Measurement Scale 2-Short Form(20-week assessment)
- Functional Assessment of Cancer Therapy-Breast(20-week assessment)
- Medical Outcomes Survey 36-item short form version(20-week assessment)
研究者
Professor Alex MOLASIOTIS
Chair Professor of Nursing and Head
The Hong Kong Polytechnic University