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

Launched by NANJING UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Jul 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether acupuncture can help reduce hot flashes in women with hormone receptor-positive breast cancer who are undergoing hormone therapy. Hot flashes are sudden feelings of warmth, often associated with menopause, and can be uncomfortable for many patients. The researchers want to compare different acupuncture treatment plans to see which one works best and to understand how acupuncture affects the brain in relation to hot flashes.

To participate in this study, women aged 18 to 75 who have been experiencing hot flashes for at least six weeks may be eligible, as long as they are currently on hormone therapy and have had surgery or chemotherapy if needed. Participants will be asked to sign a consent form and may have to complete some assessments to ensure they meet all the criteria. The study is not yet recruiting, but it aims to provide new insights into using acupuncture as a helpful option for managing hot flashes in breast cancer patients.

Gender

FEMALE

Eligibility criteria

• 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.