Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy

NCT06369168 | Completed

• 1 other identifier: Kliniken Essen-Mitte
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

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.

Conditions

Hot Flashes

Keywords

breast cancer; hot flashes; acupuncture; endocrine therapy

Outcome Measures

Primary Outcomes (1)

• subscale somato-vegetative symptoms of the Menopause Rating Scale (MRS)

  measure for hot flashes, from minimum 0 to maximum 4, with the maximum being the worst outcome

  Baseline, end of the intervention (6 weeks after the beginning), three months follow-up

Secondary Outcomes (9)

• Menopause Rating Scale (MRS) total score

  Baseline, end of the intervention (6 weeks after the beginning), three months follow-up

• Psychological symptoms and urogenital symptoms subscales of the MRS

  Baseline, end of the intervention (6 weeks after the beginning), three months follow-up

• functional assessment of cancer therapy - breast (FACT-B)

  Baseline, end of the intervention (6 weeks after the beginning), three months follow-up

• perceived stress questionnaire (PSQ)

  Baseline, end of the intervention (6 weeks after the beginning), three months follow-up

• insomnia severity index (ISI)

  Baseline, end of the intervention (6 weeks after the beginning), three months follow-up

Study Arms (3)

NADA auricular acupuncture

ACTIVE COMPARATOR

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.

Device: auricular acupuncture

balanced auricular acupuncture

ACTIVE COMPARATOR

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.

Device: auricular acupuncture

wait list control

NO INTERVENTION

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.

Interventions

auricular acupuncture DEVICE

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

NADA auricular acupuncture; balanced auricular acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead
• Karl and Veronica Carstens Foundation: collaborator

Study Sites (2)

Evang. Kliniken Essen-Mitte gGmbH

Essen, Essen, Germany

Location

Evang. Kliniken Essen-Mitte gGmbH

Essen, Germany

Location

MeSH Terms

Conditions

Hot Flashes; Breast Neoplasms

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: June 17, 2024
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-08

Locations

DE (2)