Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy

Hot Flashes Clinical Trial

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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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06369168
• Other study ID #: Kliniken Essen-Mitte
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 21, 2024
• Est. completion date: November 20, 2025

Study information

• Verified date: April 2024
• Source: Kliniken Essen-Mitte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 99
• Est. completion date: November 20, 2025
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes

Intervention

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

Locations

Country	Name	City	State
Germany	Evang. Kliniken Essen-Mitte gGmbH	Essen
Germany	Evang. Kliniken Essen-Mitte gGmbH	Essen

Sponsors (2)

Lead Sponsor	Collaborator
Kliniken Essen-Mitte	Karl and Veronica Carstens Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	adverse events (AEs)	negative side effects	current condition at baseline, end of the intervention (6 weeks after the beginning), three months follow-up