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/AClinical Study ID
NCT05613504
2022JC-55-1
Ages 30-75 Female
Study Summary
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
Connect with a study center
Jiangsu Province Hospital of Traditional Chinese Medcine
Nanjing, Jiangsu 210029
ChinaSite Not Available

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