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Trial Title:
Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
NCT ID:
NCT05613504
Condition:
Hot Flashes
Breast Cancer
Acupuncture
Conditions: Official terms:
Breast Neoplasms
Hot Flashes
Conditions: Keywords:
breast cancer
Acupuncture
Integrated PET/MRI technology
Hot flashes
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Acupuncture treatment
Description:
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.
Arm group label:
Treatment group A
Intervention type:
Other
Intervention name:
Sham acupuncture treatment
Description:
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.
Arm group label:
Treatment group B
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.
Criteria for 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.
Gender:
Female
Minimum age:
30 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Province Hospital of Traditional Chinese Medcine
Address:
City:
Nanjing
Zip:
210029
Country:
China
Contact:
Last name:
Lijun Bai, PHD
Phone:
0086-15129034948
Email:
bailijun@xjtu.edu.cn
Start date:
December 1, 2022
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Nanjing University of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Health Science Center of Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Hanzhong Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Xiang'an Hospital of Xiamen University
Agency class:
Other
Collaborator:
Agency:
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Agency class:
Other
Source:
Nanjing University of Traditional Chinese Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05613504
