STUDY PROTOCOL article
Front. Neurol.
Sec. Cognitive and Behavioral Neurology
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1565040
This article is part of the Research TopicNew Trends in Mind-Body Techniques: Boosting Wellbeing with Non-Invasive Brain Stimulation, Neurofeedback, Mindfulness, Hypnosis and Other Neuromodulatory ApproachesView all articles
Effect and Clinical Mechanism Exploration of Acupuncture Intervention for Chemotherapy-Related Cognitive Impairment (CRCI) in Triple-Negative Breast Cancer: Study Protocol for a Randomized Controlled Trial
Provisionally accepted
- 1Beijing University of Chinese Medicine, Beijing, China
- 2Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, Beijing Municipality, China
- 3Capital Medical University, Beijing, Beijing Municipality, China
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Background:Chemotherapy-Related Cognitive Impairment (CRCI) significantly impacts the quality of life of breast cancer patients. Triple-negative breast cancer (TNBC) is associated with a higher risk of cognitive decline. The occurrence of CRCI is linked to the expression of inflammatory cytokines. Currently, limited research has examined the efficacy of acupuncture for treating CRCI in TNBC patients. This randomized controlled trial aims to evaluate the effectiveness of acupuncture in managing CRCI among TNBC patients and explore the mechanism by which acupuncture treatment affects CRCI through the inflammatory signaling pathway.Methods:This study is designed as a prospective, parallel, randomized, sham-controlled, assessorblinded clinical trial. It will involve 50 patients diagnosed with TNBC who also experience CRCI. Participants will be randomly assigned to two groups, with an equal 1:1 allocation ratio into either the intervention group or the control group. Both groups will receive acupuncture sessions twice weekly for 8 weeks, with each session lasting approximately 20 minutes. The primary outcome of this study will be the percentage of subjects showing improvement in the Montreal Cognitive Assessment (MoCA) score at the end of treatment. Secondary outcome measures will include the Mini-Mental State Examination (MMSE) score, EORTC QLQ-C30 score, and the expression of inflammatory cytokines.Discussion:The findings of this study are expected to provide additional evidence supporting the efficacy of acupuncture and contribute clinical data that may elucidate the potential therapeutic mechanisms by which acupuncture ameliorates CRCI.Trial registration: https://wanalyeseww.chictr.org.cn/, identifier ChiCTR2400080147.
Keywords: chemotherapy-related cognitive impairment, Triple-negative breast cancer, cytokine, Acupuncture, Sham acupuncture, Clinical research trial
Received: 22 Jan 2025; Accepted: 16 Jun 2025.
Copyright: © 2025 Yang, Gao, Zhang, Zhang, Guo and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Qing Zhang, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, Beijing Municipality, China
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