Hot FlashesOhrHitNCT06369168
Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy
A study testing auricular acupuncture in people with Hot Flashes, run by Kliniken Essen-Mitte at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- auricular acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesGermany
- Study dates
- 17 Jun 2024to 8 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Evang. Kliniken Essen-Mitte gGmbH
Essen, Essen
Evang. Kliniken Essen-Mitte gGmbH
Essen
About this study
Official title: 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.
Read the 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
- Being tested
- auricular acupuncture
- Keywords
- breast cancer, hot flashes, acupuncture, endocrine therapy
- Medical subject headings
- Hot Flashes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupunctureDevice
two auricular acupuncture methods are compared with each other and with no treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, end of the intervention (6 weeks after the beginning), three months follow-up
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: current condition at baseline, end of the intervention (6 weeks after the beginning), three months follow-up
adverse events (AEs)
negative side effects
Measured: current condition at baseline, end of the intervention (6 weeks after the beginning), three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start17 Jun 2024
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369168
- Sponsor's protocol ID
- Kliniken Essen-Mitte
- Acronym
- OhrHit
- Status last verified
- Aug 2025
- First submitted
- 12 Apr 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Effectiveness of Auricular Acupuncture in Improving Hot Flashes During Adjuvant Endocrine Therapy in Women With Breast Cancer: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06369168
- Acronym / sponsor ID
- OhrHit / Kliniken Essen-Mitte
- Conditions
- Hot Flashes
- Keywords
- breast cancer, hot flashes, acupuncture, endocrine therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| NADA auricular acupuncture | Active comparator | Device: auricular acupuncturePatients 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. |
| balanced auricular acupuncture | Active comparator | Device: auricular acupuncturePatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auricular acupuncturetwo auricular acupuncture methods are compared with each other and with no treatment | Device | NADA auricular acupuncture, balanced auricular acupuncture |
Primary outcome
subscale somato-vegetative symptoms of the Menopause Rating Scale (MRS)
Time frame: Baseline, end of the intervention (6 weeks after the beginning), three months follow-up
measure for hot flashes, from minimum 0 to maximum 4, with the maximum being the worst outcome
9 secondary outcomes
Menopause Rating Scale (MRS) total score
Time frame: Baseline, end of the intervention (6 weeks after the beginning), three months follow-up
Psychological symptoms and urogenital symptoms subscales of the MRS
Time frame: Baseline, end of the intervention (6 weeks after the beginning), three months follow-up
functional assessment of cancer therapy - breast (FACT-B)
Time frame: Baseline, end of the intervention (6 weeks after the beginning), three months follow-up
perceived stress questionnaire (PSQ)
Time frame: Baseline, end of the intervention (6 weeks after the beginning), three months follow-up
insomnia severity index (ISI)
Time frame: Baseline, end of the intervention (6 weeks after the beginning), three months follow-up
big five inventory (BFI)
Time frame: 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
Time frame: 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
Time frame: current condition at baseline, end of the intervention (6 weeks after the beginning), three months follow-up
adverse events (AEs)
Time frame: current condition at baseline, end of the intervention (6 weeks after the beginning), three months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular acupuncture in people with Hot Flashes, run by Kliniken Essen-Mitte at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subscale somato-vegetative symptoms of the Menopause Rating Scale (MRS) (time frame: Baseline, end of the intervention (6 weeks after the beginning), three months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.