Electroacupuncture to Prevent Chemotherapy-Related Cognitive Impairment in Patients With Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- The incidence of chemotherapy-related cognitive impairment (CRCI) at the end of chemotherapy
研究概览
简要总结
The objective of this trial is to evaluate the effect of electroacupuncture compared to sham acupuncture in preventing CRCI among breast cancer patients scheduled to undergo chemotherapy.
详细描述
Participants will be randomized to receive either acupuncture or sham acupuncture treatment. Both treatments will be administered twice a week, starting one week before chemotherapy and continuing throughout the chemotherapy period. The study outcomes will be evaluated at three time points: baseline (before acupuncture and chemotherapy), during chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle). Each cycle typically lasts for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with stage I-III breast cancer
- •Scheduled to undergo chemotherapy
- •Aged between 18 and 75 years
- •MoCA score ≥ 26
- •Voluntary agreement to participate in the study and sign an informed consent
排除标准
- •Demonstrated tumor metastasis or recurrence
- •Had a prior history of chemotherapy
- •Reported a history of brain tumors, head trauma or stroke
- •Were diagnosed with cognitive function-impaired disorders, such as Alzheimer's disease
- •Were unable to cooperate with testing for any reasons
- •Had severe hepatic or renal insufficiency
- •Had hemorrhagic disorders, including von Willebrand disease, or were taking anticoagulant or antiplatelet medication
- •Had an implanted cardiac pacemaker
- •Had a history of alcohol abuse or drug addiction
- •Were participating in another interventional trial
结局指标
主要结局
The incidence of chemotherapy-related cognitive impairment (CRCI) at the end of chemotherapy
时间窗: After chemotherapy (21 days after the last chemotherapy cycle). Each chemotherapy cycle typically lasts for 4 weeks.
All participants will undergo neuropsychological assessments at baseline and after chemotherapy. CRCI is defined as two or more test scores at or below -1.5 standard deviations (SDs), or a single test score at or below -2.0 SDs from baseline to the end of chemotherapy.
次要结局
- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)(During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).)
- Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)(During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).)
- General Anxiety Disorder-7 (GAD-7)(During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).)
- Montreal Cognitive Assessment (MoCA)(During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).)
- Functional Assessment of Cancer Therapy-General (FACT-G)(During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).)
- Patient Health Questionnaire-9 (PHQ-9)(During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).)
- Insomnia Severity Index (ISI)(During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).)
研究者
Shiyan Yan
Principal Investigator
Beijing University of Chinese Medicine