Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer: Acu-CIPN, a Randomized Controlled Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Reduction of peripheral neuropathy, including neuropathic pain
研究概览
简要总结
The main purpose of this study is to define whether acupuncture in addition to the treatment of physician choice as per standard of care leads to a greater decrease of neuropathic pain as perceived by women with breast cancer who suffer from chemotherapy-induced peripheral neuropathy. Peripheral neuropathy and neuropathic pain of hands and foots will be assessed by using a Number Rate Scale (NRS scale) and data will be compared between standard of care treatment group and acupuncture in addition to standard of care treatment group.
详细描述
Patients with breast cancer diagnosis and taxane-induced peripheral neuropathy since at least 1 week (CTCAE4.0 Grade 1-3 and NRS≥4) will be enrolled. Patients will be randomized 1:1 in the 2 treatment arms: treatment of physician choice as per standard of care vs acupuncture in addition to standard of care treatment. In experimental arm acupuncture will be performed twice a week for 6 weeks, for a total of 12 sessions. Peripheral neuropathy symptoms and pain at hands and foot will be recorded every day by patients by use of NRS scale. At baseline and every 3 weeks patients will complete CIPN20, EORTC QL30, SF-36 and BPI in order to compare the course of neuropathic pain and quality of life in the 2 arms.
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
- 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
- •Female patients ≥18 years.
- •Patients with diagnosis of breast cancer (stage I-III) currently receiving taxane-based chemotherapy (paclitaxel or docetaxel) in neoadjuvant or adjuvant setting, or who have completed taxane-based chemotherapy for no more than 6 months. Concomitant treatment with trastuzumab is allowed in HER-positive patients and/or hormone therapy in patients with hormone-sensitive breast cancer.
- •Chemotherapy-induced peripheral neuropathy graded 1-3, according to NCICTCAE v 4.03 criteria, for at least one week and for no more than 6 months after the completion of chemotherapy regimen.
- •Neuropathic pain with ≥4 points in the numeric scale rate for at least one week
- •Informed consent signed before any study-specific procedure
排除标准
- •Patients with diagnosis of metastatic breast cancer
- •Pre-existing peripheral neuropathy in the 28-day period before the start of chemotherapy
- •Any pre-existing condition which can both lead to or be a concomitant factor for neuropathy onset, such as not controlled diabetes mellitus, paralysis, multiple sclerosis, AIDS and Herpes Zoster
- •Patients with amputation and/or severe peripheral vascular disease (peripheral revascularization interventions needed, AOCP> stage II, rheumatologic disorders affecting arteriole or microcirculation)
- •Patient with history of spinal cord surgery
- •Patient with history of chronic alcoholism
- •Concomitant use of pharmacological agents which can cause neuropathic pain as an adverse event, except for chemotherapy
- •Patient who already experienced acupuncture for any condition
- •Patient currently in treatment with duloxetine, gabapentin, pregabalin or other drugs for the treatment of neuropathic pain
- •Patient with history of psychiatric disorders before breast cancer diagnosis (major depressive disorders, bipolar disorder, suicidal tendency)
研究组 & 干预措施
Arm A
Treatment for peripheral neuropathy (including neuropathic pain), according to the standard of care (e.g. "Cetirizine", "Gabapentin"). Patient will be followed-up as per protocol for a total of 9 weeks .
干预措施: treatment of physician choice, according to the standard of care (Drug)
Arm B
In addition to the treatment for peripheral neuropathy and neuropathic pain, according to the standard of care (e.g. "Cetirizine", "Gabapentin"), patient will receive acupuncture administration twice a week and for a 6-week treatment period. Patient will also be followed-up for 3 weeks after the end of treatment.
干预措施: Acupuncture (Procedure)
Arm B
In addition to the treatment for peripheral neuropathy and neuropathic pain, according to the standard of care (e.g. "Cetirizine", "Gabapentin"), patient will receive acupuncture administration twice a week and for a 6-week treatment period. Patient will also be followed-up for 3 weeks after the end of treatment.
干预措施: treatment of physician choice, according to the standard of care (Drug)
结局指标
主要结局
Reduction of peripheral neuropathy, including neuropathic pain
时间窗: 6 weeks after the start of treatment
Reduction of peripheral neuropathy, including neuropathic pain (at least 3 points on the numeric scale rate) after the 6-week treatment period versus before the start of treatment, greater in the experimental than in the control arm.
次要结局
- Improvement of peripheral neuropathy, including neuropathic pain, EORTC QLQ-CIPN20/QLQ-C30 questionnaires(at 3, 6, 9 weeks after the start of treatment)
- Reduction of peripheral neuropathy, including neuropathic pain(at 3 and 6 weeks after the start of treatment)
- Improvement of the quality of life, SF-36 questionnaire(6 weeks after the start of treatment)
- Improvement of peripheral neuropathy, including neuropathic pain, BPI questionnaire(6 weeks after the start of treatment)
- Improvement of peripheral neuropathy, including neuropathic pain, NCICTCAE v 4.03 criteria(at 3, 6, 9 weeks after the start of treatment)
- Type and frequency of adverse events occurrence due to acupuncture(at last visit, 9 weeks from start of treatment)
研究者
Claudio Zamagni MD
MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna