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

Launched by NANJING UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Nov 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how acupuncture can help reduce hot flashes in women who have hormone receptor-positive breast cancer. Hot flashes are sudden feelings of warmth, often uncomfortable, which can be a side effect of hormone therapy used in breast cancer treatment. The researchers want to see if different acupuncture treatment methods can effectively relieve these hot flashes and to better understand how acupuncture works in this context using advanced imaging technology.

To join the study, participants need to be women aged 30 to 75 who have been on hormone therapy for at least four weeks and have been experiencing frequent hot flashes for the same amount of time. They should have a specific level of hot flashes and must be healthy enough to participate. However, women with active cancer that has spread, certain health issues, or those on specific medications for hot flashes will not be eligible. Participants can expect to receive acupuncture treatments and will be closely monitored throughout the trial. It’s important to know that this trial is not yet recruiting, so women interested in participating will need to wait until recruitment begins.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Aged 30-75 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;
• • 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 chemotherapy (if any);
• • Eastern Cooperative Oncology Group score of 0-1 points.
• • Sign the informed consent and participate in the clinical observation voluntarily.
• 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;
• • Patients receiving phytoestrogens, tibolone or analogs, verapril, or specific homeopathic medicines;
• • 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, pregnant or breastfeeding 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.