[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acupuncture-treatment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acupuncture-treatment":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100615571","a-randomized-controlled-trial-of-acupuncture-for-the-management-of-hot-flashes-in-patients-with-hormone-receptor-positive-breast-cancer-100615571",false,"NCT07294339","A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positive Breast Cancer","针刺治疗激素受体阳性乳腺癌患者潮热的随机对照试验研究，A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positive Breast Cancer","ACU-HRBC-HF","Inclusion Criteria Female patients aged 18 to 75 years. Histopathologically confirmed breast cancer, currently receiving endocrine therapy (e.g., selective estrogen receptor modulators and\u002For aromatase inhibitors, CDK4\u002F6 inhibitors), with or without ovarian function suppression, for at least 4 weeks and ongoing at the time of enrollment.\n\nExpected 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.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1:\n\n0: Fully active, able to carry on all pre-disease performance without restriction;\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out light work (e.g., housework, office work);\n2. Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours;\n3. Capable of only limited self-care; confined to bed or chair more than 50% of waking hours;\n4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair;\n5. Dead. Willing and able to participate in the study and sign the informed consent form.\n\nExclusion Criteria Evidence of tumor metastasis, currently undergoing radiotherapy, chemotherapy, or having a planned surgery.\n\nUse of selective serotonin reuptake inhibitors (SSRIs) and\u002For anticonvulsants or other pharmacologic agents for hot flash management within 4 weeks prior to study entry.\n\nUnstable cardiac disease or myocardial infarction within 6 months prior to study initiation.\n\nRecent initiation or modification of endocrine therapy within 1 week, or planned initiation or modification within 14 weeks.\n\nHistory 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.\n\nWithdrawal Criteria Failure to complete acupuncture treatment per protocol, making efficacy evaluation impossible.\n\nUse of medications or treatments during the trial that may affect study outcomes.\n\nVoluntary withdrawal from the study during treatment.\n\nDiscontinuation Criteria Serious adverse events, complications, or physiological changes during treatment that make continuation unsafe or impractical.\n\nLoss to follow-up or death after enrollment. Participant's voluntary withdrawal at any stage of treatment.","FEMALE","18 Years","75 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nThis 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.",[28,29,30],"Acupuncture Treatment","Hormone Receptor-Positive Breast Cancer","Hot Flashes",[29,30,32,33],"Acupuncture","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-03-18",{"date":37,"type":38},"2026-03-19","ACTUAL",{"date":40,"type":22},"2026-04-01",{"date":42,"type":22},"2027-10-01",{"name":44,"class":45},"Peking University People's Hospital","OTHER"]