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)
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
168
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yu KE, PhD
- 電話番号：+65 66836174
- メール：ke.yu@nccs.com.sg
研究連絡先のバックアップ
- 名前：Benton PT TAM, MSc
- メール：benton.tam.p.t@nccs.com.sg
研究場所
-
-
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Singapore、シンガポール、168583
- National Cancer Center Singapore
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コンタクト：
- Yu KE, PhD
- 電話番号：66836174
- メール：ke.yu@nccs.com.sg
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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偽コンパレータ：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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介入なし：Waitlist control arm
Each participant will continue to receive usual care, but will not receive electroacupuncture or other acupuncture treatments.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Objective cognitive function - multitasking
時間枠：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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).
|
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Objective cognitive function - learning and memory
時間枠：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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).
|
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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Objective cognitive function - sustained attention
時間枠：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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).
|
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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Objective cognitive function - response speed
時間枠：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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).
|
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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Objective cognitive function - working memory
時間枠：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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).
|
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Subjective cognitive function
時間枠：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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
時間枠：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)
時間枠：Baseline, 13 weeks after baseline, and 17 weeks after baseline.
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Yu KE, PhD、National Cancer Centre, Singapore
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2028年10月31日
研究の完了 (推定)
2029年1月13日
試験登録日
最初に提出
2026年4月24日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月13日
QC基準を満たした最後の更新が送信されました
2026年5月6日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。