Electroacupuncture for Cognitive Toxicity in Cancer Survivors: Assessing Implementation, Cost, and Effectiveness for Integration

Официальное название

ElectroAcupuncture to Manage Symptoms of Cognitive Toxicity in Cancer Survivors: Assessing impLementation, Cost, and effectIveness for inteGratioN (EAST-ALIGN)

Обзор

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)

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Objective cognitive function - multitasking [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Objective cognitive function - learning and memory [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Objective cognitive function - sustained attention [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Objective cognitive function - response speed [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Objective cognitive function - working memory [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]

Вторичные конечные точки (12)

• Subjective cognitive function [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Fatigue [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Symptom burden [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Work productivity [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Health utility [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Biomarkers - plasma BDNF [Срок оценки: 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) [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Biomarkers - epigenetic ageing [Срок оценки: Baseline, 13 weeks after baseline, and 17 weeks after baseline.]
• Safety assessment [Срок оценки: 13 weeks after baseline and 17 weeks after baseline.]
• Implementation - acceptability of electroacupuncture treatment [Срок оценки: 13 weeks after baseline.]
• Implementation - adoption of EA [Срок оценки: From commencement of study recruitment till the end of recruitment, assessed up to 3 years.]
• Implementation - treatment fidelity [Срок оценки: 13 weeks after baseline.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Сингапур · 1 центр

• National Cancer Center Singapore — Singapore

Публикации

• 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. PMID 24716504
• 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. PMID 32146576
• 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. PMID 22396443
• 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
• Bolton G, Isaacs A. Women's experiences of cancer-related cognitive impairment, its impact on daily life and care received for it following treatment for breast cancer. Psychol Health Med. 2018 Dec;23(10):1261-1274. doi: 10.1080/13548506.2018.1500023. Epub 2018 Jul 26. PMID 30048158
• Yang Y, Von Ah D. Cancer-related cognitive impairment: updates to treatment, the need for more evidence, and impact on quality of life-a narrative review. Ann Palliat Med. 2024 Sep;13(5):1265-1280. doi: 10.21037/apm-24-70. Epub 2024 Sep 9. PMID 39260437
• Dorland HF, Abma FI, Roelen CAM, Stewart RE, Amick BC, Ranchor AV, Bultmann U. Work functioning trajectories in cancer patients: Results from the longitudinal Work Life after Cancer (WOLICA) study. Int J Cancer. 2017 Nov 1;141(9):1751-1762. doi: 10.1002/ijc.30876. Epub 2017 Jul 19. PMID 28681478

Идентификаторы

NCT: NCT07583979 · 2026-0516

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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