Electroacupuncture for Cognitive Toxicity in Cancer Survivors: Assessing Implementation, Cost, and Effectiveness for Integration (EAST-ALIGN)
6 mai 2026 mis à jour par: 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)
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
168
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yu KE, PhD
- Numéro de téléphone: +65 66836174
- E-mail: ke.yu@nccs.com.sg
Sauvegarde des contacts de l'étude
- Nom: Benton PT TAM, MSc
- E-mail: benton.tam.p.t@nccs.com.sg
Lieux d'étude
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Singapore, Singapour, 168583
- National Cancer Center Singapore
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Contact:
- Yu KE, PhD
- Numéro de téléphone: 66836174
- E-mail: ke.yu@nccs.com.sg
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur factice: 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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Aucune intervention: Waitlist control arm
Each participant will continue to receive usual care, but will not receive electroacupuncture or other acupuncture treatments.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Objective cognitive function - multitasking
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Subjective cognitive function
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Yu KE, PhD, National Cancer Centre, Singapore
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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- Wefel JS, Vardy J, Ahles T, Schagen SB. International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. Lancet Oncol. 2011 Jul;12(7):703-8. doi: 10.1016/S1470-2045(10)70294-1. Epub 2011 Feb 25.
- Cheung YT, Ng T, Shwe M, Ho HK, Foo KM, Cham MT, Lee JA, Fan G, Tan YP, Yong WS, Madhukumar P, Loo SK, Ang SF, Wong M, Chay WY, Ooi WS, Dent RA, Yap YS, Ng R, Chan A. Association of proinflammatory cytokines and chemotherapy-associated cognitive impairment in breast cancer patients: a multi-centered, prospective, cohort study. Ann Oncol. 2015 Jul;26(7):1446-51. doi: 10.1093/annonc/mdv206. Epub 2015 Apr 28.
- Cheung YT, Shwe M, Tan YP, Fan G, Ng R, Chan A. Cognitive changes in multiethnic Asian breast cancer patients: a focus group study. Ann Oncol. 2012 Oct;23(10):2547-2552. doi: 10.1093/annonc/mds029. Epub 2012 Mar 6.
- Cheung YT, Lim SR, Ho HK, Chan A. Cytokines as mediators of chemotherapy-associated cognitive changes: current evidence, limitations and directions for future research. PLoS One. 2013 Dec 5;8(12):e81234. doi: 10.1371/journal.pone.0081234. eCollection 2013.
- Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.
- Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of cancer-related cognitive impairment. Int Rev Psychiatry. 2014 Feb;26(1):102-13. doi: 10.3109/09540261.2013.864260.
- Wesevich A, Johnson K, Altomare I: Cancer-Related Cognitive Impairment, 2021, pp 139-152
- Cerulla Torrente N, Navarro Pastor JB, de la Osa Chaparro N. Systematic review of cognitive sequelae of non-central nervous system cancer and cancer therapy. J Cancer Surviv. 2020 Aug;14(4):464-482. doi: 10.1007/s11764-020-00870-2. Epub 2020 Mar 7.
- Moreno AM, Hamilton RA, Currier MB: Chapter 20 - Cancer-Related Cognitive Impairment: Diagnosis, Pathogenesis, and Management, in Cristian A (ed): Breast Cancer and Gynecologic Cancer Rehabilitation. St. Louis, Elsevier, 2021, pp 211-223
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- Cheng X: Chinese acupuncture and moxibustion. Beijing, China, Foreign Language Press, 1987
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- Lim S. WHO Standard Acupuncture Point Locations. Evid Based Complement Alternat Med. 2010 Jun;7(2):167-8. doi: 10.1093/ecam/nep006. Epub 2009 Feb 24.
- Cheung YT, Tan EH, Chan A. An evaluation on the neuropsychological tests used in the assessment of postchemotherapy cognitive changes in breast cancer survivors. Support Care Cancer. 2012 Jul;20(7):1361-75. doi: 10.1007/s00520-012-1445-4. Epub 2012 Apr 5.
- Vardy J, Wefel JS, Ahles T, Tannock IF, Schagen SB. Cancer and cancer-therapy related cognitive dysfunction: an international perspective from the Venice cognitive workshop. Ann Oncol. 2008 Apr;19(4):623-9. doi: 10.1093/annonc/mdm500. Epub 2007 Oct 31.
- Cheung YT, Foo YL, Shwe M, Tan YP, Fan G, Yong WS, Madhukumar P, Ooi WS, Chay WY, Dent RA, Ang SF, Lo SK, Yap YS, Ng R, Chan A. Minimal clinically important difference (MCID) for the functional assessment of cancer therapy: cognitive function (FACT-Cog) in breast cancer patients. J Clin Epidemiol. 2014 Jul;67(7):811-20. doi: 10.1016/j.jclinepi.2013.12.011. Epub 2014 Mar 18.
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- Sayer M, Ng DQ, Chan R, Kober K, Chan A. Current evidence supporting associations of DNA methylation measurements with survivorship burdens in cancer survivors: A scoping review. Cancer Med. 2024 Jul;13(13):e7470. doi: 10.1002/cam4.7470.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
31 octobre 2028
Achèvement de l'étude (Estimé)
13 janvier 2029
Dates d'inscription aux études
Première soumission
24 avril 2026
Première soumission répondant aux critères de contrôle qualité
6 mai 2026
Première publication (Réel)
13 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-0516
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .