Electroacupuncture for Cognitive Toxicity in Cancer Survivors: Assessing Implementation, Cost, and Effectiveness for Integration (EAST-ALIGN)
2026年5月6日 更新者：National Cancer Centre, Singapore
ElectroAcupuncture to Manage Symptoms of Cognitive Toxicity in Cancer Survivors: Assessing impLementation, Cost, and effectIveness for inteGratioN (EAST-ALIGN)
The goal of this clinical trial is to evaluate the clinical effectiveness and understand the biological mechanisms of electroacupuncture (EA) in reducing cognitive toxicity among cancer survivors. The study aims are:
- To evaluate the clinical effectiveness of a 10-week EA regimen targeting neuropsychiatric-related acupoints in reducing cognitive toxicity among cancer survivors in Singapore.
- To explore the biological mechanisms underlying EA's effects on cognitive function.
- To assess the early implementation of EA for managing cognitive toxicity in cancer survivors.
Researchers will compare results from the true EA arm, sham EA arm and waitlist control arm, to see if electroacupuncture can help improve cognitive issues related to cancer and its treatment, how it may work, and what factors may affect how it is delivered in cancer care.
Participants will:
- Be assigned to either of the 3 arms (true EA, sham EA, waitlist control)
- Received 10 EA sessions (if assigned to true or sham EA arm)
- Complete 3 study assessment visits at baseline, Week 13, and Week 17
- Be invited to a one-time interview to share their study experience (optional, if selected)
研究概览
详细说明
Electroacupuncture (EA) is a promising, emerging intervention to manage cognitive toxicity among patients with cancer.
The primary goal of the EAST-ALIGN study is to evaluate the clinical effectiveness and understand the biological mechanisms of EA in reducing cognitive toxicity among cancer survivors through a randomized, blinded sham and waitlist controlled, clinical trial.
Simultaneously, the investigators will collect implementation data on engaging community Traditional Chinese Medicine (TCM) practitioners to deliver EA.
This approach facilitates the early identification and resolution of implementation barriers, accelerating EA adoption into clinical practice if proven effective.
研究类型
介入性
注册 (估计的)
168
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yu KE, PhD
- 电话号码：+65 66836174
- 邮箱：ke.yu@nccs.com.sg
研究联系人备份
- 姓名：Benton PT TAM, MSc
- 邮箱：benton.tam.p.t@nccs.com.sg
学习地点
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Singapore、新加坡、168583
- National Cancer Center Singapore
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接触：
- Yu KE, PhD
- 电话号码：66836174
- 邮箱：ke.yu@nccs.com.sg
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Survivor participants
- Aged 21-85 years
- Documented cancer diagnosis in electronic health records
- Perceived by the survivor or oncology care provider that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment
- Able to understand English or Mandarin
- Able to provide informed consent
Stakeholder participants
- Aged ≥21 years
- Identified as having a relevant role, experience, or perspective relating to the delivery, referral, coordination, or implementation of EA or supportive cancer care in the study context
- Able to provide informed consent
Exclusion Criteria:
Survivor participants
- Presence of brain metastases
- Severe needle phobia
- Known bleeding disorder (e.g. hemophilia, von Willebrand disease, thrombocytopenia).
- Current use of antiplatelet or anticoagulant therapy (e.g. aspirin, clopidogrel, warfarin, enoxaparin, rivaroxaban, dabigatran)
- Known blood-borne communicable disease (e.g. hepatitis B, hepatitis C, human immunodeficiency virus)
- Presence of a pacemaker or other electronic implant, or a history of epilepsy
- Current acupuncture treatment or acupuncture received within the past 3 months
- Current pregnancy, planned pregnancy over the next 5 months, or breastfeeding.
- Incapable of providing informed consent
- Unable to complete study procedures
Stakeholder participants
- Incapable of providing informed consent
- Unable to complete study procedures
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：True electroacupuncture arm
Each participant will receive 10 electroacupuncture treatment sessions over the course of 10-12 weeks.
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Electroacupuncture is administered at 13 predefined acupoints: Shenting (GV24), Baihui (DU20), Sishencong (EX-HN1), Zhongwan (CV12), Guanyuan (CV4), Neiguan (PC6, bilateral), Shenmen (HT7, bilateral), Zusanli (ST36, bilateral), Sanyinjiao (SP6, bilateral), Taixi (KI3, bilateral), Zhaohai (KI6, bilateral), Hegu (LI4, bilateral), and Taichong (LIV3, bilateral.
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假比较器：Sham electroacupuncture arm
Each participant will receive 10 sham electroacupuncture sessions designed to mimic treatment without therapeutic stimulation over the course of 10-12 weeks.
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Electroacupuncture is administered at predefined non-disease related acupoints: Pianli (LI6) bilateral, Wenliu (LI7) bilateral, Futu (ST32) bilateral, Xiajuxu (ST39) bilateral, Daheng (SP15) bilateral, and Jiaosun (TE20) bilateral.
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无干预：Waitlist control arm
Each participant will continue to receive usual care, but will not receive electroacupuncture or other acupuncture treatments.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Objective cognitive function - multitasking
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Multitasking Test, a computerized cognitive testing software.
Score ranges from 0-160, with a lower score reflecting better performance.
Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Multitasking Test).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Objective cognitive function - learning and memory
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Paired Associates Learning Test, a computerized cognitive testing software.
Score ranges from 0-70, with a lower score reflecting better performance.
Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Paired Associates Learning Test).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Objective cognitive function - sustained attention
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Rapid Visual Information Processing Test, a computerized cognitive testing software.
Score ranges from 0-1, with a higher score reflecting better performance.
Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Rapid Visual Information Processing Test).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Objective cognitive function - response speed
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Reaction Time Test, a computerized cognitive testing software.
Score ranges from 100-5100 ms, with a lower score reflecting faster reaction time.
Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Reaction Time Test).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Objective cognitive function - working memory
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Spatial Working Memory Test, a computerized cognitive testing software.
Score ranges from 0-153, with a lower score reflecting better performance.
Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Spatial Working Memory Test).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Subjective cognitive function
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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The Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) version 3 is a validated 37-item questionnaire assessing self-perceived subjective cognitive function.
The total FACT-Cog score is summed from all items (range: 0-148), with higher scores indicating better subjective cognitive functioning.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Fatigue
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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The Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) is a validated questionnaire that comprises 30 items and contains 5 subscales, each with 6 items: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor.
The total MFSI-SF score is obtained by subtracting the vigor subscale from the sum of all items (range: 24-96), with a higher score indicating higher fatigue level.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Symptom burden
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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The Rotterdam Symptom Checklist (RSCL) is a validated self-report measure of quality of life in patients with cancer.
It includes 30 symptom items, 8 activity items, and 1 overall quality-of-life item.
The symptom distress score combines the physical symptom distress scale (23 items, range 23-92) and, psychological distress scale (7 items, range 7-28), for a total range of 30-120.
Higher scores indicate greater symptom burden, distress, or quality of life.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Work productivity
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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The Work Productivity and Activity Impairment (WPAI) questionnaire is a patient-reported outcome measure that assesses the impact of health problems on work productivity and regular activities, including absenteeism, presenteeism, overall work impairment, and activity impairment.
Scores in each of these four areas are expressed as a percentage from 0% to 100%, with higher scores indicating greater impairment and worse productivity.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Health utility
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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EuroQOL Group 5-Dimension (EQ-5D-5L) contains a 5-item descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression; a visual analogue scale (VAS) measuring overall health status.
EQ-5D Index Value (Utility Score) ranges from 0 to 1.0 with higher value indicating better health-related quality of life.
The VAS ranges from 0 to 100, with higher scores reflecting better self-rated health.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Biomarkers - plasma BDNF
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Plasma brain-derived neurotropic factor levels at each time point will be analyzed from blood samples collected.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Biomarkers - plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha)
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Plasma concentrations of interleukin-1 beta (IL-1β), interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and tumor necrosis factor-alpha (TNF-alpha) will be measured from blood samples.
Each cytokine will be reported in picograms per milliliter (pg/mL).
Higher values indicate higher plasma cytokine concentrations.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Biomarkers - epigenetic ageing
大体时间：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Epigenetic ageing will be assessed using DNA methylation-based biological age metrics derived from blood samples.
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Safety assessment
大体时间：13 weeks after baseline and 17 weeks after baseline.
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Participants will be monitored for adverse events and the severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
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13 weeks after baseline and 17 weeks after baseline.
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Implementation - acceptability of electroacupuncture treatment
大体时间：13 weeks after baseline.
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Participants in the true and sham EA arms will complete a questionnaire evaluating their perceptions towards the true/sham EA treatment.
Participants will be asked if they are satisfied and benefited from the treatment, and whether they would consider undergoing treatment again outside of a trial setting.
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13 weeks after baseline.
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Implementation - adoption of EA
大体时间：From commencement of study recruitment till the end of recruitment, assessed up to 3 years.
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Adoption will be evaluated by tracking study enrollment logs, including the number of eligible individuals approached, the number recruited, and documented reasons for non-participation when available.
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From commencement of study recruitment till the end of recruitment, assessed up to 3 years.
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Implementation - treatment fidelity
大体时间：13 weeks after baseline.
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Treatment fidelity will be assessed from standardized treatment logs for each true/sham EA session by the TCM practitioners.
For blinding assessment, participants in the true and sham EA arms will be asked to guess their treatment arm allocation (True EA/ Sham EA/ Don't know).
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13 weeks after baseline.
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Implementation - feasibility
大体时间：17 weeks after baseline, through study completion, estimated as up to 3 years.
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Semi-structured interviews conducted using an interview guide developed based on the Consolidated Framework for Implementation Research (CFIR).
Semi-structured interviews with key stakeholders (TCM practitioners, tertiary healthcare providers, clinical operations staff) to identify barriers and facilitators to integrating EA into routine oncology care.
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17 weeks after baseline, through study completion, estimated as up to 3 years.
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Implementation - implementation cost
大体时间：From commencement of study recruitment, through study completion, estimated as up to 3 years.
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Implementation cost will be assessed using a time-driven activity-based costing approach.
A structured activity log will be maintained by study personnel to document the time and resources required for each implementation activity, including personnel effort and fixed consumable resources.
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From commencement of study recruitment, through study completion, estimated as up to 3 years.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Yu KE, PhD、National Cancer Centre, Singapore
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2028年10月31日
研究完成 (估计的)
2029年1月13日
研究注册日期
首次提交
2026年4月24日
首先提交符合 QC 标准的
2026年5月6日
首次发布 (实际的)
2026年5月13日
研究记录更新
最后更新发布 (实际的)
2026年5月13日
上次提交的符合 QC 标准的更新
2026年5月6日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.