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

Last updated: July 19, 2022
Sponsor: Nanjing University of Traditional Chinese Medicine
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT05460819
2022JC-55
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18-75 years old;
  • Adjuvant hormone therapy (eg, tamoxifen and/or aromatase inhibitors) with or withoutovarian function suppression has been administered for at least 4 weeks and iscurrently 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 morethan 14 hot flashes per week (2 times per day) in the week before inclusion in thestudy, 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

Exclusion Criteria:

  • Tumor metastases, undergoing chemoradiotherapy or planning surgery;
  • Pharmacological intervention for hot flashes with hot flash treatment drugs such asselective serotonin reuptake inhibitors (SSRIs) and/or anticonvulsants for at least 4weeks 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 tostart 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

Total Participants: 90
Study Start date:
August 01, 2022
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • Jiangsu Province Hospital of Traditional Chinese Medcine

    Nanjing, Jiangsu 210029
    China

    Site Not Available

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