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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05613504
• Other study ID #: 2022JC-55-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2027

Study information

• Verified date: November 2022
• Source: Nanjing University of Traditional Chinese Medicine
• Contact: Lijun Bai, phd
• Phone: 0086-15129034948
• Email: bailijun[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Breast Cancer
• Breast Neoplasms
• Hot Flashes

Intervention

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.
• 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: ? Shallow needling scheme: use a disposable sterile acupuncture needle, insert the needle 0.2 inch, without twisting, and keep the needle for 20 minutes. ?Non-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.

Locations

Country	Name	City	State
China	Jiangsu Province Hospital of Traditional Chinese Medcine	Nanjing	Jiangsu

Sponsors (5)

Lead Sponsor	Collaborator
Nanjing University of Traditional Chinese Medicine	Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine, Hanzhong Hospital of Traditional Chinese Medicine, School of Life Science and Technology, Xi'an Jiaotong University, Xiang'an Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 8, 12,24 weeks later
Primary	Change in acupuncture efficacy expectation assessment	Acupuncture efficacy expectation assessment scores will be assessed with acupuncture efficacy expectation assessment. The minimum value is 0 , and the maximum value is 20. The higher scores mean a better outcome.	Baseline, 8, 12,24 weeks later
Primary	Change of functional connectivity of whole brain	Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence.	Baseline, 8, 12,24 weeks later
Primary	Change of metabolism of glucose in the brain	Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography.	Baseline, 8, 12,24 weeks later
Primary	Change of hot flash severity	Hot flash severity will be assessed with hot flash scores each week. There are four levels of severity: Mild: Duration: Less than five minutes. Symptoms: warmth, discomfort, flushing. Moderate: Duration: Up to fifteen minutes. Symptoms: warmth in head, neck, ears, or body; tense, tight muscles; clammy skin; change in heart rate or rhythm; light sweating; dry mouth.; Severe: Duration: Up to twenty minutes. Symptoms: Fever, sometimes like a crucible or burning sensation; change in heart rate or rhythm; feeling faint; headache; heavy sweating.; Very severe: Duration: Up to forty-five minutes. Symptoms: boiling heat; constant sweating; trouble breathing; feeling faint, dizzy; leg cramps or feeling cramps; change in heart rate; stomach upset.; The greater severity mean a worse outcome.	Baseline, 8, 12,24 weeks later
Secondary	Change in sleep	Sleep scores will be assessed with Pittsburgh sleep quality index.The minimum value is 9, and the maximum value is 36. The higher scores mean a worse outcome.	Baseline, 8, 12,24 weeks later