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/AClinical Study ID
NCT05460819
2022JC-55
Ages 18-75 Female
Study Summary
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
Connect with a study center
Jiangsu Province Hospital of Traditional Chinese Medcine
Nanjing, Jiangsu 210029
ChinaSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.