Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
NCT05613504 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2022-11-16
Summary
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 integrated PET/MRI technology.
Conditions
- Hot Flashes
- Breast Cancer
- Acupuncture
Interventions
- OTHER
-
Acupuncture treatment
Acupoint selection: 4 general points + syndrome differentiation acupoints (select or replace 2-4 acupoints according to symptom 1, select 1-2 acupoints according to symptom 2 and symptom 3), and adjust acupoints according to symptoms every week. 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.
- OTHER
-
Sham acupuncture treatment
Acupoint selection: According to the selected acupoints of the electroacupuncture group, 5-7 positions were selected at the non-meridian and non-acupoint 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.
Sponsors & Collaborators
-
Xi'an Jiaotong University
collaborator OTHER -
Hanzhong Hospital of Traditional Chinese Medicine
collaborator UNKNOWN -
Xiang'an Hospital of Xiamen University
collaborator OTHER -
Dongzhimen Hospital, Beijing
collaborator OTHER -
Nanjing University of Traditional Chinese Medicine
lead OTHER
Principal Investigators
-
Lijun Bai · Xi'an Jiaotong University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-01
- Primary Completion
- 2027-12-01
- Completion
- 2027-12-01
Countries
- China
Study Locations
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