Auricular acupuncture for hot flashes in breast cancer patients undergoing therapy
Effect and Effectiveness of Auricular Acupuncture in Improving Hot Flashes During Adjuvant Endocrine Therapy in Women With Breast Cancer: A Randomized Controlled Study
NA · Kliniken Essen-Mitte · NCT06369168
This study is testing if auricular acupuncture can help women with hormone receptor-positive breast cancer reduce hot flashes and improve their quality of life while they are undergoing treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Kliniken Essen-Mitte (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Essen and 1 other locations) |
| Trial ID | NCT06369168 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of auricular acupuncture on hot flashes experienced by women undergoing adjuvant endocrine therapy for hormone receptor-positive breast cancer. It employs a three-armed randomized controlled design to compare the efficacy of balanced ear acupuncture with NADA ear acupuncture. The study aims to assess not only the reduction in hot flashes but also the impact on quality of life, fatigue, stress perception, and sleep quality among participants. The trial addresses a significant side effect of endocrine therapy, which can lead to treatment non-adherence.
Who should consider this trial
Good fit: Ideal candidates are women with a histologically confirmed diagnosis of non-metastatic hormone receptor-positive breast cancer who are currently undergoing adjuvant endocrine therapy and experiencing hot flashes.
Not a fit: Patients who are currently undergoing chemotherapy, radiotherapy, or have severe psychiatric comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective non-hormonal treatment option for managing hot flashes in breast cancer patients, improving their quality of life.
How similar studies have performed: Previous studies have shown positive effects of body acupuncture on hot flashes, suggesting potential success for this novel approach using auricular acupuncture.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed diagnosis of non-metastatic hormone receptor-positive breast CA (TNM stage I-III) under adjuvant endocrine therapy * hot flashes, measured with the MRS (Menopause Rating Scale) * willingness to participate in the study and signed informed consent Exclusion Criteria: * ongoing or planned chemotherapy, radiotherapy, follow-up treatment or reconstructive plastic surgery during the study period * severe physical or psychopharmacologically treated psychiatric comorbidity, due to which a patient is unable to participate in the study * pregnancy * participation in other clinical trials with behavioural, psychological or complementary medicine, psychological or complementary medical interventions * regular use of barbiturates, antidepressants, abuse of drugs and/or alcohol * ongoing acupuncture treatment * lack of ability to complete the questionnaires independently * operations or infections in the area to be acupunctured
Where this trial is running
Essen and 1 other locations
- Evang. Kliniken Essen-Mitte gGmbH — Essen, Germany (RECRUITING)
- Evang. Kliniken Essen-Mitte gGmbH — Essen, Germany (RECRUITING)
Study contacts
- Study coordinator: Bettina Adler, Dr.
- Email: b.adler@kem-med.com
- Phone: 020117439061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hot Flashes, breast cancer, hot flashes, acupuncture, endocrine therapy