Clinical trial NCT05613504: Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
Official title: A Randomized Controlled Trial Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hot Flashes
Breast Cancer
Acupuncture
Keywords: breast cancer
Acupuncture
Integrated PET/MRI technology
Hot flashes
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Xi'an Jiaotong University
name: Hanzhong Hospital of Traditional Chinese Medicine
name: Xiang'an Hospital of Xiamen University
name: Dongzhimen Hospital, Beijing
First posted: 2022-11-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Change in cancer therapy functional assessment
timeFrame: Baseline, 8, 12，24 weeks later
measure: Change in acupuncture efficacy expectation assessment
timeFrame: Baseline, 8, 12，24 weeks later
measure: Change of functional connectivity of whole brain
timeFrame: Baseline, 8, 12，24 weeks later
measure: Change of metabolism of glucose in the brain
timeFrame: Baseline, 8, 12，24 weeks later
measure: Change of hot flash severity
timeFrame: Baseline, 8, 12，24 weeks later
Secondary outcomes:
measure: Change in sleep
timeFrame: Baseline, 8, 12，24 weeks later
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Traditional Chinese Medcine
state: Jiangsu
Study officials:
affiliation: Xi'an Jiaotong University
name: Lijun Bai
role: STUDY_DIRECTOR
References: