Acupuncture for Taxane-Induced Peripheral Neuropathy Prevention (ATP): A Phase II Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 13
- 主要终点
- Neuropathic Pain Scale (NPS)
研究概览
简要总结
Some people experience a side effect while they are receiving taxane called taxane-induced peripheral neuropathy (TIPN). TIPN is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life. The purpose of this study is to learn if acupuncture can prevent TIPN from getting worse. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body. We will compare real acupuncture (RA) to placebo (sham) acupuncture (SA). SA is done like RA, but will use different needles and target different sites or places on the body than RA. We are comparing RA to SA to learn whether RA can prevent TIPN from getting worse while receiving taxane.
详细描述
The study will include two phases. The first phase is the screening phase, in which patients with early stage breast cancer undergoing taxane therapy will consent and receive TIPN screening each week till they develop grade 1 or higher by CTCAE criteria. The patients with TIPN grade 1 or higher will then be consented to the intervention phase, in which patients will be randomized to receive either weekly real or sham acupuncture treatment using a standardized, semi-fixed protocol developed in our preliminary studies to improve TIPN pain. The participant may also participate in Part 2 of the study if they begin to experience TIPN but do not participate in Part 1.
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 (Participant, Investigator)
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
- •Screening Phase:
- •English or Spanish-proficient men and women aged ≥18 years
- •Histological diagnoses of invasive carcinoma of the breast
- •Plan to receive curative intent chemotherapy regimen containing 12 weeks weekly paclitaxel or nab-paclitaxel as standard of care
- •Intervention Phase:
- •TIPN grade ≥1 based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, developed while receiving taxane
- •≥ 4 4 weeks of either weekly paclitaxel or nab-paclitaxel, or paclitaxel or abraxane with dosing every 2-3 weeks planned, as standard of care and at treating physician's discretion
- •Willing to adhere to requirement that no new pain medication or dose changes 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
- •Screening Phase:
- •Pre-existing peripheral neuropathy within 28 days of screening consent
- •Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
- •Intervention Phase:
- •Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
- •Use of acupuncture for symptom management within 28 days of intervention consent
研究组 & 干预措施
real acupuncture (RA)
Real Acupuncture weekly till taxane completion
干预措施: Real Acupuncture (Procedure)
sham acupuncture (SA)
Sham Acupuncture weekly till taxane completion
干预措施: Sham Acupuncture (Other)
结局指标
主要结局
Neuropathic Pain Scale (NPS)
时间窗: at 4 weeks
Evaluate the effectiveness of real acupuncture versus sham acupuncture in preventing TIPN progression as measured by the Neuropathic Pain Scale (NPS) in patients with early stage breast cancer who are receiving curative intent weekly taxane containing regimen and who have grade ≥ 1 TIPN
次要结局
未报告次要终点