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Electroacupuncture for Cognitive Toxicity in Cancer Survivors: Assessing Implementation, Cost, and Effectiveness for Integration (EAST-ALIGN)

6 maggio 2026 aggiornato da: 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)

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

168

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Singapore
      • Singapore, Singapore, 168583
        • National Cancer Center Singapore
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: True electroacupuncture arm
Each participant will receive 10 electroacupuncture treatment sessions over the course of 10-12 weeks.
Dispositivo: True electroacupuncture
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.
Comparatore fittizio: 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.
Dispositivo: Sham electroacupuncture
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.
Nessun intervento: Waitlist control arm
Each participant will continue to receive usual care, but will not receive electroacupuncture or other acupuncture treatments.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective cognitive function - multitasking
Lasso di tempo: 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.
Objective cognitive function - learning and memory
Lasso di tempo: 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.
Objective cognitive function - sustained attention
Lasso di tempo: 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.
Objective cognitive function - response speed
Lasso di tempo: 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.
Objective cognitive function - working memory
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Subjective cognitive function
Lasso di tempo: 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.
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Fatigue
Lasso di tempo: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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.
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Symptom burden
Lasso di tempo: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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.
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Work productivity
Lasso di tempo: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
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.
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Health utility
Lasso di tempo: 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.
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Biomarkers - plasma BDNF
Lasso di tempo: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Plasma brain-derived neurotropic factor levels at each time point will be analyzed from blood samples collected.
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Biomarkers - plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha)
Lasso di tempo: 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.
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Biomarkers - epigenetic ageing
Lasso di tempo: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Epigenetic ageing will be assessed using DNA methylation-based biological age metrics derived from blood samples.
Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Safety assessment
Lasso di tempo: 13 weeks after baseline and 17 weeks after baseline.
Participants will be monitored for adverse events and the severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
13 weeks after baseline and 17 weeks after baseline.
Implementation - acceptability of electroacupuncture treatment
Lasso di tempo: 13 weeks after baseline.
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.
13 weeks after baseline.
Implementation - adoption of EA
Lasso di tempo: From commencement of study recruitment till the end of recruitment, assessed up to 3 years.
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.
From commencement of study recruitment till the end of recruitment, assessed up to 3 years.
Implementation - treatment fidelity
Lasso di tempo: 13 weeks after baseline.
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).
13 weeks after baseline.
Implementation - feasibility
Lasso di tempo: 17 weeks after baseline, through study completion, estimated as up to 3 years.
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.
17 weeks after baseline, through study completion, estimated as up to 3 years.
Implementation - implementation cost
Lasso di tempo: From commencement of study recruitment, through study completion, estimated as up to 3 years.
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.
From commencement of study recruitment, through study completion, estimated as up to 3 years.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Centre, Singapore

Collaboratori

Singapore Thong Chai Medical Institution

Investigatori

  • Cattedra di studio: Yu KE, PhD, National Cancer Centre, Singapore

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

31 ottobre 2028

Completamento dello studio (Stimato)

13 gennaio 2029

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

13 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-0516

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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