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

BackgroundChemotherapy-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. Cu...

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Main Authors: Wenqi Yang, Qing Zhang, Chong Gao, Jingzhi Zhang, Xingwei Guo, Xin Liu
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-07-01
Series:Frontiers in Neurology
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Online Access:https://www.frontiersin.org/articles/10.3389/fneur.2025.1565040/full
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author Wenqi Yang
Wenqi Yang
Qing Zhang
Chong Gao
Jingzhi Zhang
Jingzhi Zhang
Xingwei Guo
Xingwei Guo
Xin Liu
Xin Liu
author_facet Wenqi Yang
Wenqi Yang
Qing Zhang
Chong Gao
Jingzhi Zhang
Jingzhi Zhang
Xingwei Guo
Xingwei Guo
Xin Liu
Xin Liu
author_sort Wenqi Yang
collection DOAJ
description BackgroundChemotherapy-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.MethodsThis study is designed as a prospective, parallel, randomized, sham-controlled, assessor-blinded 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 min. 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.DiscussionThe 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 registrationhttps://www.chictr.org.cn/showproj.html?proj=218356, identifier: ChiCTR2400080147.
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spelling doaj-art-d4fe9d7675d94e68a871119fa882342a2025-07-23T05:35:51ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-07-011610.3389/fneur.2025.15650401565040Effect and clinical mechanism exploration of acupuncture intervention for chemotherapy-related cognitive impairment (CRCI) in triple-negative breast cancer: study protocol for a randomized controlled trialWenqi Yang0Wenqi Yang1Qing Zhang2Chong Gao3Jingzhi Zhang4Jingzhi Zhang5Xingwei Guo6Xingwei Guo7Xin Liu8Xin Liu9Graduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaDepartment of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaDepartment of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaDepartment of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaGraduate School, Capital Medical University, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, ChinaBackgroundChemotherapy-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.MethodsThis study is designed as a prospective, parallel, randomized, sham-controlled, assessor-blinded 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 min. 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.DiscussionThe 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 registrationhttps://www.chictr.org.cn/showproj.html?proj=218356, identifier: ChiCTR2400080147.https://www.frontiersin.org/articles/10.3389/fneur.2025.1565040/fullchemotherapy-related cognitive impairmenttriple-negative breast cancercytokineacupuncturesham acupunctureclinical research trial
spellingShingle Wenqi Yang
Wenqi Yang
Qing Zhang
Chong Gao
Jingzhi Zhang
Jingzhi Zhang
Xingwei Guo
Xingwei Guo
Xin Liu
Xin Liu
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
Frontiers in Neurology
chemotherapy-related cognitive impairment
triple-negative breast cancer
cytokine
acupuncture
sham acupuncture
clinical research trial
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic chemotherapy-related cognitive impairment
triple-negative breast cancer
cytokine
acupuncture
sham acupuncture
clinical research trial
url https://www.frontiersin.org/articles/10.3389/fneur.2025.1565040/full
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