Acupuncture for Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.

NCT ID: NCT05460819

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2027-07-31

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 functional magnetic resonance imaging 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.

Conditions

Hot Flashes; Breast Cancer; Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment group A

Treatment group A was given endocrine and acupuncture treatment for 8 weeks (24 times in total, 3 times a week); followed up for 16 weeks, no acupuncture treatment.

Group Type: EXPERIMENTAL

Acupuncture treatment

Intervention Type: OTHER

Acupoint selection: Hegu-Yinxi acupoint group (clearing heat and relieving sweat), Sanyinjiao-Fuliu acupoint group (nourishing yin and tonifying kidney), Tianshu-uteri acupoint group (special effect points) (12 acupoints on both sides).

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.

Treatment group B

Treatment group B was given endocrine and sham acupuncture treatment for 8 weeks, followed up for 16 weeks, no acupuncture during the period, and after 16 weeks, received standardized acupuncture for 8 weeks (24 times in total, 3 times a week).

Group Type: SHAM_COMPARATOR

Sham Acupuncture treatment

Intervention Type: OTHER

Selecting acupoints: Select the side opening positions of the 6 acupuncture points in the real acupuncture group, and select non-meridian and non-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.

control

The control group was given conventional adjuvant endocrine therapy, premenopausal patients received tamoxifen therapy, and postmenopausal patients received aromatase inhibitor or tamoxifen therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture treatment

Acupoint selection: Hegu-Yinxi acupoint group (clearing heat and relieving sweat), Sanyinjiao-Fuliu acupoint group (nourishing yin and tonifying kidney), Tianshu-uteri acupoint group (special effect points) (12 acupoints on both sides).

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.

Intervention Type: OTHER

Sham Acupuncture treatment

Selecting acupoints: Select the side opening positions of the 6 acupuncture points in the real acupuncture group, and select non-meridian and non-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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18-75 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;
• Vasomotor syndrome for at least 6 weeks;
• Premenopausal or postmenopausal patients;
• 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 after chemotherapy (if any);
• Eastern Cooperative Oncology Group score of 0-1 points.
• Sign the informed consent and voluntarily participate in this clinical observation.

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;
• Unstable heart disease or myocardial infarction within 6 months prior to study start;
• 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;
• Seizures of unknown likelihood or history of seizures;
• Have used acupuncture for hot flashes within 6 months prior to the start of the study;
• Pregnant or breastfeeding patients;
• Apparent uncontrolled infection;
• Mental illness or family history; neurological disorder or family history.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Nanjing University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Qianyan Liu

Principal Investgator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lijun Bai, phd

Role: STUDY_DIRECTOR

Xi'an Jiaotong University

Locations

Jiangsu Province Hospital of Traditional Chinese Medcine

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Lijun Bai, phd

Role: CONTACT

bailijun@xjtu.edu.cn

0086-15129034948

Facility Contacts

Lijun Bai, PHD

Role: primary

bailijun@xjtu.edu.cn

0086-15129034948

Other Identifiers

2022JC-55

Identifier Type: -

Identifier Source: org_study_id