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

6. Mai 2026 aktualisiert von: 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)

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

168

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Singapur
      • Singapore, Singapur, 168583
        • National Cancer Center Singapore
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: True electroacupuncture arm
Each participant will receive 10 electroacupuncture treatment sessions over the course of 10-12 weeks.
Gerät: 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.
Schein-Komparator: 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.
Gerät: 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.
Kein Eingriff: Waitlist control arm
Each participant will continue to receive usual care, but will not receive electroacupuncture or other acupuncture treatments.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Objective cognitive function - multitasking
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Subjective cognitive function
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Cancer Centre, Singapore

Mitarbeiter

Singapore Thong Chai Medical Institution

Ermittler

  • Studienstuhl: Yu KE, PhD, National Cancer Centre, Singapore

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Oktober 2028

Studienabschluss (Geschätzt)

13. Januar 2029

Studienanmeldedaten

Zuerst eingereicht

24. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-0516

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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