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

Not Applicable
Not yet recruiting
Conditions
Hot Flashes
Acupuncture
Breast Cancer
Interventions
Other: Acupuncture treatment
Other: Sham Acupuncture treatment
Registration Number
NCT05460819
Lead Sponsor
Nanjing University of Traditional Chinese Medicine
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
90
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Treatment group AAcupuncture treatmentTreatment 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 group BSham Acupuncture treatmentTreatment 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).
Primary Outcome Measures
NameTimeMethod
Change in acupuncture efficacy expectation assessmentBaseline, 8,24 weeks later

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.

Change of functional connectivity of whole brainBaseline, 8,24 weeks later

Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence.

Change in cancer therapy functional assessmentBaseline, 8,24 weeks later

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.

Change of metabolism of glucose in the brainBaseline, 8,24 weeks later

Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography.

Change of hot flash severityBaseline, 8,24 weeks later

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.

Secondary Outcome Measures
NameTimeMethod
Change in sleepBaseline, 8,24 weeks later

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.

Trial Locations

Locations (1)

Jiangsu Province Hospital of Traditional Chinese Medcine

🇨🇳

Nanjing, Jiangsu, China

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