# 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

## TL;DR

This study will test if acupuncture helps reduce cognitive issues in triple-negative breast cancer patients undergoing chemotherapy and explore how it might work.

## Contribution

This is the first randomized controlled trial to investigate acupuncture's effect on CRCI in triple-negative breast cancer patients and its potential inflammatory mechanisms.

## Key findings

- Acupuncture may improve cognitive function in TNBC patients with CRCI.
- The study will explore how acupuncture affects inflammatory cytokines linked to CRCI.
- Results could provide clinical evidence for acupuncture's role in managing CRCI.

## Abstract

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.

This 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.

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.

https://www.chictr.org.cn/showproj.html?proj=218356, identifier: ChiCTR2400080147.