Effect and Effectiveness of Auricular Acupuncture in Improving Hot Flashes During Adjuvant Endocrine Therapy in Women With Breast Cancer: A Randomized Controlled Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

With this clinical trial we investigate whether auricular acupuncture during adjuvant endocrine therapy has an improving effect on hot flashes, which are often perceived as psychologically and physically stressful in self-assessment of women with breast cancer. Empirical studies indicate that body acupuncture has positive effects on hot flashes. As auricular acupuncture offers a number of advantages over body acupuncture, a three-armed randomised controlled research design is being used to investigate whether hot flashes caused by endocrine therapy are also reduced by ear acupuncture. Balanced ear acupuncture will be compared with NADA ear acupuncture in terms of efficacy and effectiveness. In addition, the effects of the two forms of therapy on the patients' individual quality of life, fatigue, stress perception and sleep quality will be analysed.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Evang. Kliniken Essen-Mitte gGmbH
RECRUITING
Essen
Evang. Kliniken Essen-Mitte gGmbH
RECRUITING
Essen
Contact Information
Primary
Bettina Adler, Dr.
b.adler@kem-med.com
020117439061
Backup
Petra Voiss, PD Dr.
p.voiss@kem-med.com
020117439001
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2025-12-20
Participants
Target number of participants: 99
Treatments
Active_comparator: NADA auricular acupuncture
Patients in one intervention group are treated twice a week for five weeks with balanced ear acupuncture.The data sets of those subjects who received at least eight balanced ear acupuncture treatments will be compared with those who got NADA acupuncture and those who were not treated.
Active_comparator: balanced auricular acupuncture
Patients in the other intervention group are treated twice a week for five weeks with NADA ear acupuncture. The data sets of those subjects who received at least eight NADA ear acupuncture treatments will be compared with those who got balanced ear acupuncture and those who were not treated.
No_intervention: wait list control
Control group: At the end of the 3-month follow-up, the patients in the control group received 10 ear acupuncture treatments in a group setting.
Related Therapeutic Areas
Sponsors
Collaborators: Karl and Veronica Carstens Foundation
Leads: Kliniken Essen-Mitte

This content was sourced from clinicaltrials.gov

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