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

NCT07294339 | Not Yet Recruiting

• 1 other identifier: PekingUPH-LM2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hormone Receptor-Positive Breast Cancer; Hot Flashes; Acupuncture Treatment

Keywords

Hormone Receptor-Positive Breast Cancer; Hot Flashes; Acupuncture; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (3)

• Hot Flash Assessment

  4 months

• Quality of Life Assessment

  4 months

• Sleep Quality

  4 months

Other Outcomes (1)

• Exploratory Outcome Measures

  4 months

Study Arms (2)

Endocrine therapy + True acupuncture

EXPERIMENTAL

Other: True Acupuncture

Endocrine therapy + Sham acupuncture

OTHER

Other: Sham Acupuncture

Interventions

True Acupuncture OTHER

Acupoints: 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.

Endocrine therapy + True acupuncture

Sham Acupuncture OTHER

Points: 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.

Endocrine therapy + Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female Hormone Receptor-Positive Breast Cancer patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• : Fully active, able to carry on all pre-disease performance without restriction;
• 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;
• Dead. Willing and able to participate in the study and sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, 100000, China

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Miao Liu, Dr.

CONTACT

010-88324010; liumiao@pkuph.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of breast center

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)