A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positive Breast Cancer

Inclusion Criteria Female patients aged 18 to 75 years. Histopathologically confirmed breast cancer, currently receiving endocrine therapy (e.g., selective estrogen receptor modulators and/or aromatase inhibitors, CDK4/6 inhibitors), with or without ovarian function suppression, for at least 4 weeks and ongoing at the time of enrollment.

Expected survival time \> 6 months. Experiencing persistent hot flashes for at least 4 weeks, with a frequency of ≥14 episodes per week (≥2 per day) during the week prior to enrollment, and a Hot Flash Composite Score (HFCS) of 3-4.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1:

0: Fully active, able to carry on all pre-disease performance without restriction;

1. Restricted in physically strenuous activity but ambulatory and able to carry out light work (e.g., housework, office work);
2. Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours;
3. Capable of only limited self-care; confined to bed or chair more than 50% of waking hours;
4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair;
5. Dead. Willing and able to participate in the study and sign the informed consent form.

Exclusion Criteria Evidence of tumor metastasis, currently undergoing radiotherapy, chemotherapy, or having a planned surgery.

Use of selective serotonin reuptake inhibitors (SSRIs) and/or anticonvulsants or other pharmacologic agents for hot flash management within 4 weeks prior to study entry.

Unstable cardiac disease or myocardial infarction within 6 months prior to study initiation.

Recent initiation or modification of endocrine therapy within 1 week, or planned initiation or modification within 14 weeks.

History or risk of seizure of unclear etiology. Prior acupuncture treatment for hot flashes within 6 months before enrollment. Contraindications to MRI scanning. Pregnant or lactating women. Presence of uncontrolled active infection. Severe psychiatric disorders or family history of psychiatric or neurological diseases.

Withdrawal Criteria Failure to complete acupuncture treatment per protocol, making efficacy evaluation impossible.

Use of medications or treatments during the trial that may affect study outcomes.

Voluntary withdrawal from the study during treatment.

Discontinuation Criteria Serious adverse events, complications, or physiological changes during treatment that make continuation unsafe or impractical.

Loss to follow-up or death after enrollment. Participant's voluntary withdrawal at any stage of treatment.