Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy (OhrHit)

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

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.

Study Overview

• Status: Completed
• Conditions: Hot Flashes
• Intervention / Treatment: Device: auricular acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, Essen
    • Evang. Kliniken Essen-Mitte gGmbh
  • Essen, Germany
    • Evang. Kliniken Essen-Mitte gGmbh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: auricular acupuncture; two auricular acupuncture methods are compared with each other and with no treatment
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.
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.	Device: auricular acupuncture; two auricular acupuncture methods are compared with each other and with no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events (AEs)	negative side effects	current condition at baseline, end of the intervention (6 weeks after the beginning), three months follow-up
Menopause Rating Scale (MRS) total score	self-administered scale to assess menopausal symptoms and complaints, to evaluate the severity of symptoms over time, and to measure changes pre- and postmenopause replacement therapy, 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
Psychological symptoms and urogenital symptoms subscales of the MRS	subscale of the MRS, 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
functional assessment of cancer therapy - breast (FACT-B)	Quality of life; physical and emotional wellbeing: from minimum 0 to maximum 4, with the maximum being the worst outcome, social relationships, sexual life satisfaction, and functionality: from minimum 0 to maximum 4, with the maximum being the best outcome	Baseline, end of the intervention (6 weeks after the beginning), three months follow-up
perceived stress questionnaire (PSQ)	stress, from minimum 0 to maximum 4, with the maximum being the strongest agreement to the statements	Baseline, end of the intervention (6 weeks after the beginning), three months follow-up
insomnia severity index (ISI)	insomnia severity, 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
big five inventory (BFI)	fatigue, with minimum 1 to maximum 10, with the maximum being the worst outcome	current condition at baseline, end of the intervention (6 weeks after the beginning), three months follow-up
Expected effect of the respective intervention on a 100mm visual analogue scale	expected effect of the treatment and fulfilling of the expectation, from minimum 1 to maximum 10, with the maximum being the highest expectation	baseline, end of the intervention (6 weeks after the beginning), three months follow-up
intensity and degree of impairment due to hot flashes on a 100mm visual analogue scale	individual extent of hot flashes, from minimum 1 to maximum 10, with the maximum being the worst outcome	current condition at baseline, end of the intervention (6 weeks after the beginning), three months follow-up

Collaborators and Investigators

• Sponsor: Kliniken Essen-Mitte
• Collaborators: Karl and Veronica Carstens Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Actual): September 8, 2025
• Study Completion (Actual): September 8, 2025

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; acupuncture; hot flashes; endocrine therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Breast Neoplasms; Hot Flashes; Therapeutics; Complementary Therapies; Acupuncture Therapy; Auriculotherapy; Acupuncture, Ear
• Other Study ID Numbers: Kliniken Essen-Mitte

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No