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

Nanjing University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Breast Cancer; Acupuncture; Hot Flashes

Treatments: Other: Sham Acupuncture treatment; Other: Acupuncture treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05460819

2022JC-55

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Treatment group A

Experimental group

Description:

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.

Treatment:

Other: Acupuncture treatment

Treatment group B

Sham Comparator group

Description:

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).

Treatment:

Other: Sham Acupuncture treatment

control

No Intervention group

Description:

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