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

Last updated: November 11, 2022
Sponsor: Nanjing University of Traditional Chinese Medicine
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT05613504
2022JC-55-1
  • Ages 30-75
  • 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 integrated PET/MRI technology.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 30-75 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;
  • 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 chemotherapy (if any);
  • Eastern Cooperative Oncology Group score of 0-1 points.
  • Sign the informed consent and participate in the clinical observation voluntarily.

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;
  • Patients receiving phytoestrogens, tibolone or analogs, verapril, or specifichomeopathic medicines;
  • Started or changed adjuvant hormone therapy within the past week, or who planned tostart or change adjuvant hormone therapy in the past 14 weeks, pregnant orbreastfeeding 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.

Study Design

Total Participants: 90
Study Start date:
December 01, 2022
Estimated Completion Date:
December 01, 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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