Clinical trial · Interventional
Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy
Effect and Effectiveness of Auricular Acupuncture in Improving Hot Flashes During Adjuvant Endocrine Therapy in Women With Breast Cancer: A Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| auricular acupuncture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- NADA auricular acupuncture
- description
- 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.
- interventionNames
- Device: auricular acupuncture
- type
- ACTIVE_COMPARATOR
- label
- balanced auricular acupuncture
- description
- 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.
- interventionNames
- Device: auricular acupuncture
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available