This study intends to further evaluate the efficacy of acupuncture by comparing the intervention effects of different acupuncture treatment regimens on hot flashes in breast cancer ; and to explore the central effect regulation mechanism of acupuncture intervention on hot flashes based on functional magnetic resonance imaging technology.
Aged 18-75 years old;
Adjuvant hormone therapy (eg, tamoxifen and/or aromatase inhibitors) with or without ovarian function suppression has been administered for at least 4 weeks and is currently on treatment;
Vasomotor syndrome for at least 6 weeks;
Premenopausal or postmenopausal patients;
Tumor metastases, undergoing chemoradiotherapy or planning surgery;
Pharmacological intervention for hot flashes with hot flash treatment drugs such as selective serotonin reuptake inhibitors (SSRIs) and/or anticonvulsants for at least 4 weeks prior to study initiation;
Unstable heart disease or myocardial infarction within 6 months prior to study start;
Started or changed adjuvant hormone therapy within the past week, or who planned to start or change adjuvant hormone therapy in the past 14 weeks;
Parallel
Acupuncture treatment
Other interventionAcupoint selection: Hegu-Yinxi acupoint group (clearing heat and relieving sweat), Sanyinjiao-Fuliu acupoint group (nourishing yin and tonifying kidney), Tianshu-uteri acupoint group (special effect points) (12 acupoints on both sides). Frequency: 3 times a week (once every other day) for a total of 8 weeks of continuous treatment. Operation: Use a one-time sterile acupuncture needle (0.30×40mm, Huatuo brand), insert the needle 0.5 inch along the anatomical position, level up and relieve the qi, and keep the needle for 20 minutes.
Sham Acupuncture treatment
Other interventionSelecting acupoints: Select the side opening positions of the 6 acupuncture points in the real acupuncture group, and select non-meridian and non-points (points with less nerve distribution, sparseness, and rich muscles). Frequency: 3 times a week (once every other day) for a total of 8 weeks of continuous treatment. Operation: ① Shallow needling scheme: use a disposable sterile acupuncture needle, insert the needle 0.2 inch, without twisting, and keep the needle for 20 minutes. ②Non-invasive acupuncture plan: choose a special comfort needle with no needle tip at the top of the needle, paste a disposable sterile foam pad on the non-acupoint, and use a disposable sterile flat head The acupuncture needles were pierced into the foam pad, lightly touching but not piercing the skin, and not breathing; the needles were kept for 20 minutes.
Change in cancer therapy functional assessment
Cancer therapy functional assessment scores will be assessed with Cancer Therapy Functional Assessment-Breast cancer, version 4.The minimum value is 0 , and the maximum value is 185. The higher scores mean a worse outcome.
Change in acupuncture efficacy expectation assessment
Acupuncture efficacy expectation assessment scores will be assessed with acupuncture efficacy expectation assessment. The minimum value is 0 , and the maximum value is 20. The higher scores mean a better outcome.
Change of functional connectivity of whole brain
Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence.
Change of metabolism of glucose in the brain
Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography.
Change in sleep
Sleep scores will be assessed with Pittsburgh sleep quality index.The minimum value is 9, and the maximum value is 36. The higher scores mean a worse outcome.
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Nanjing University of Traditional Chinese Medicine
Lead sponsor
Xi'an Jiaotong University
Collaborator
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