A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 255
- 试验地点
- 6
- 主要终点
- Difference of pain severity from baseline to 4 weeks after baseline.
研究概览
简要总结
This study is a randomized controlled trial of electroacupuncture (referred to as EA) versus sham acupuncture (referred to as EA) as effective treatments for Chemotherapy-Induced Peripheral Neuropathy (CIPN) pain in cancer survivors.
详细描述
During the study, patients will be randomized to one of the two possible acupuncture treatment groups and receive 10 treatments over the course of 8 weeks and then enter a follow-up period. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. EA involves adding a very small amount of electricity through the acupuncture needles (electrical stimulation). Researchers have found that EA can increase the effects of regular acupuncture, and it is particularly helpful for treating different kinds of pain. The purpose of this study is to learn if EA can improve CIPN pain in cancer survivors, and if it is effective against other CIPN-related symptoms.
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 (Participant)
盲法说明
Randomization will occur before the baseline assessments are administered. Each site will randomize its own patients through RedCap. Once the patient is randomized, the site acupuncture team will be notified via RedCap alert in order to provide the appropriate treatment. Patients and non-acupuncturist members of the study team will be blinded to which acupuncture group the patient was assigned. The acupuncturists and one clinical research coordinator will be the only ones unblinded. The clinical research coordinator will be unblinded in order to assist acupuncturists to confirm randomization. This clinical research coordinator will not be the primary research coordinator in the study and will not have direct contact with the patient. The rest of the study coinvestigators and staff will remain blinded.
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
- •English-proficient men and women aged ≥18 years
- •Free of oncologic disease by clinical examination and history
- •Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment
- •Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia
- •Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- •Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week
- •On a stable regimen (no change in the past three months) if taking anti-neuropathy or other pain medications
- •Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period
- •Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments
排除标准
- •Patients with a pacemaker or other electronically charged medical device
- •Use of acupuncture for symptom management within the past 12 months
研究组 & 干预措施
Electroacupuncture Arm
The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.
干预措施: Electroacupuncture (Other)
Sham Acupuncture Arm
The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.
干预措施: Sham Acupuncture (Other)
结局指标
主要结局
Difference of pain severity from baseline to 4 weeks after baseline.
时间窗: 4 weeks
The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form (BPI-SF)
Difference of pain severity from baseline to 8 weeks after baseline.
时间窗: 8 weeks
The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form
次要结局
未报告次要终点
研究者
Weidong Lu, MB, MPH, PhD
Principal Investigator
Dana-Farber Cancer Institute