Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
Hot Flashes, Breast Cancer, Acupuncture
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring breast cancer, Acupuncture, Integrated PET/MRI technology, Hot flashes
Eligibility Criteria
Inclusion Criteria: Aged 30-75 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; Patients with persistent hot flashes for at least 4 weeks and with a frequency of more than 14 hot flashes per week (2 times per day) in the week before inclusion in the study, the weekly average hot flash composite score is 3-4; Patients after surgery and chemotherapy (if any); Eastern Cooperative Oncology Group score of 0-1 points. Sign the informed consent and participate in the clinical observation voluntarily. Exclusion Criteria: 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; Patients receiving phytoestrogens, tibolone or analogs, verapril, or specific homeopathic medicines; 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, pregnant or breastfeeding patients; Bleeding or coagulation disorders with obvious uncontrolled infection Psychiatric illness or family history; neurological disorder or family history; seizure possibility or history of seizures.
Sites / Locations
- Jiangsu Province Hospital of Traditional Chinese Medcine
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Sham Comparator
No Intervention
Treatment group A
Treatment group B
control
Treatment group A was given endocrine and acupuncture treatment for 8 weeks (24 times in total, 3 times a week); followed up for 16 weeks, no acupuncture treatment.
Treatment group B was given endocrine and sham acupuncture treatment for 8 weeks, followed up for 16 weeks, no acupuncture during the period, and after 16 weeks, received standardized acupuncture for 8 weeks (24 times in total, 3 times a week).
The control group was given conventional adjuvant endocrine therapy, premenopausal patients received tamoxifen therapy, and postmenopausal patients received aromatase inhibitor or tamoxifen therapy.