Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy

NCT ID: NCT06369168

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2025-09-08

Brief 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.

Detailed Description

In Germany, one in eight women will develop breast cancer in her lifetime, with a relative 5-year survival rate of 88%. Around 70 % of breast cancer cases are hormone receptor positive. Adjuvant endocrine therapy is recommended to reduce the risk of recurrence.The results of a systematic review show that around 52.4 % to 84.8 % of patients adhere to the treatment. It was also shown that non-adherence to treatment has a negative impact on the risk of breast cancer recurrence and the development of distant metastases, as well as on mortality. Lack of adherence to treatment is related, among other things, to the side effects of endocrine therapy, which significantly reduce quality of life. In particular, musculoskeletal syndrome and sleep disorders lead to discontinuation of endocrine treatment with an aromatase inhibitor. Many patients also suffer from hot flashes, sexual dysfunction, weight gain, bone density loss, depression, cognitive dysfunction and fatigue.

The study focuses on hot flashes, which have a negative impact on sleep and promote symptoms of fatigue. Due to the endocrine therapy, the symptoms are usually more pronounced than the menopause-related symptoms. However, oestrogen-based hormone replacement therapy is contraindicated, while non-hormonal medication such as venlafaxine or gabapentin often have serious side effects. An alternative is body acupuncture, which can decrease hot flashes in women with breast cancer. One of the advantages of acupuncture compared to drug treatments is that it is considered having very few side effects.

With the help of a three-armed randomized controlled research design, this study aims to investigate the efficacy and effectiveness of balanced ear acupuncture compared to NADA ear acupuncture in the treatment of hot flashes caused by endocrine therapy. In addition, the effects of the two forms of therapy on the individual quality of life, fatigue, stress perception and sleep quality of the patients will be analyzed.The respective results will be compared with those of a control group that did not receive acupuncture during the observation period.

Conditions

Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

auricular acupuncture

Intervention Type: DEVICE

two auricular acupuncture methods are compared with each other and with no treatment

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.

Group Type: ACTIVE_COMPARATOR

auricular acupuncture

Intervention Type: DEVICE

two auricular acupuncture methods are compared with each other and with no treatment

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

auricular acupuncture

two auricular acupuncture methods are compared with each other and with no treatment

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karl and Veronica Carstens Foundation

OTHER

Sponsor Role: collaborator

Kliniken Essen-Mitte

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Evang. Kliniken Essen-Mitte gGmbH

Essen, , Germany

Evang. Kliniken Essen-Mitte gGmbH

Essen, , Germany

Countries

Germany

Other Identifiers

Kliniken Essen-Mitte

Identifier Type: -

Identifier Source: org_study_id