Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.

N/ANot Yet RecruitingNCT05613504

Nanjing University of Traditional Chinese Medicine90 enrolled

Overview

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.

This topic combines the theory of "unblocking the governor and warming the yang" with the important findings of modern research, that is, the important mechanism of the spine in the pathogenesis of breast cancer, and innovatively proposes the technique of unblocking the governor and treating the spine. Prospective clinical intervention research in rehabilitation, objectively evaluate the clinical efficacy, advantages and disadvantages of this technology, so as to effectively break through the current application dilemma of acupuncture and bone-setting manipulation in tumor diseases.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hot Flashes Breast Cancer Acupuncture

Interventions

Acupuncture treatmentOTHER

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.

Sham acupuncture treatmentOTHER

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jiangsu Province Hospital of Traditional Chinese Medcine

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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.