Hot flashes are among the most common and distressing adverse effects experienced by patients receiving endocrine therapy for hormone receptor-positive breast cancer. Hormone replacement therapy (HRT) and non-hormonal medications can alleviate symptoms but are limited by side effects and safety concerns, leading to poor adherence. Acupuncture, a traditional Chinese medical therapy involving percutaneous stimulation of specific acupoints, has shown potential to reduce the frequency and severity of hot flashes with minimal adverse events.
This randomized, parallel-controlled clinical trial aims to evaluate the efficacy and safety of acupuncture in managing hot flashes in postoperative breast cancer patients undergoing endocrine therapy. Sixty eligible patients with stage I-III hormone receptor-positive breast cancer will be randomly assigned in a 1:1 ratio to receive either true acupuncture or sham acupuncture, three times per week for eight weeks, followed by a 16-week follow-up period without acupuncture. Functional magnetic resonance imaging (fMRI) will be employed to explore neural mechanisms underlying acupuncture's effects, alongside assessments of hot flash frequency, quality of life (FACT-B+ES), sleep quality (PSQI), and serum biomarkers related to endocrine and neuropeptide regulation. The results are expected to provide evidence for the efficacy and central mechanisms of acupuncture in managing hot flashes in breast cancer patients.
Restricted in physically strenuous activity but ambulatory and able to carry out light work (e.g., housework, office work);
Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours;
Capable of only limited self-care; confined to bed or chair more than 50% of waking hours;
Completely disabled; cannot carry on any self-care; totally confined to bed or chair;
None
Parallel
True Acupuncture
Other interventionAcupoints: Sanyinjiao (SP6), Taixi (KI3), Taichong (LR3), Zusanli (ST36) Frequency: 3 sessions per week, for 8 consecutive weeks (24 sessions total) Procedure: Needles inserted to a depth of 0.5 cun, electrical stimulation at 2 Hz, even reinforcing-reducing manipulation until "Deqi" sensation achieved; needles retained for 30 minutes.
Sham Acupuncture
Other interventionPoints: Non-meridian, non-acupoint sites located 0.5-1 cm lateral to true points Frequency: 3 sessions per week, for 8 consecutive weeks Procedure: Needles inserted superficially (0.2 cun) without manipulation or "Deqi" sensation; 2 Hz electrical stimulation applied for 30 minutes.
Cranial fMRI Imaging Evaluation and Data Analysis
Functional magnetic resonance imaging (fMRI) of the brain will be performed before, during, and after treatment, as well as at the end of follow-up, to assess changes in brain structural and functional imaging characteristics.
Hot Flash Assessment
Hot flash severity and interference with daily life will be evaluated using the Hot Flash Related Daily Interference Scale (HFRDIS). The frequency of hot flashes during the week prior to each follow-up visit will also be recorded and statistically compared between the two groups.
Quality of Life Assessment
Quality of life will be measured using the Functional Assessment of Cancer Therapy-Breast plus Endocrine Subscale (FACT-B, Version 4). The total scores of all subdomains will be analyzed and compared between groups.
Sleep Quality
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI).
Exploratory Outcome Measures
Exploratory biomarkers will be assessed in peripheral blood samples, including gonadal hormones - follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), testosterone (T), and prolactin (PRL) - as well as serotonin (5-HT) and calcitonin gene-related peptide (CGRP).
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