Electroacupuncture for Cognitive Toxicity in Cancer Survivors: Assessing Implementation, Cost, and Effectiveness for Integration (EAST-ALIGN)
6 de maio de 2026 atualizado por: 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)
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
168
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yu KE, PhD
- Número de telefone: +65 66836174
- E-mail: ke.yu@nccs.com.sg
Estude backup de contato
- Nome: Benton PT TAM, MSc
- E-mail: benton.tam.p.t@nccs.com.sg
Locais de estudo
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Singapore, Cingapura, 168583
- National Cancer Center Singapore
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Contato:
- Yu KE, PhD
- Número de telefone: 66836174
- E-mail: ke.yu@nccs.com.sg
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Falso: 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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Sem intervenção: Waitlist control arm
Each participant will continue to receive usual care, but will not receive electroacupuncture or other acupuncture treatments.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Objective cognitive function - multitasking
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Objective cognitive function - working memory
Prazo: 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).
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Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Subjective cognitive function
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Yu KE, PhD, National Cancer Centre, Singapore
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
31 de outubro de 2028
Conclusão do estudo (Estimado)
13 de janeiro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
24 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de maio de 2026
Primeira postagem (Real)
13 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-0516
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .