Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369168
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-04-12
Brief Title:
Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy
Sponsor:
Kliniken Essen-Mitte
Organization:
Kliniken Essen-Mitte
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OhrHit
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
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 recurrenceThe results of a systematic review show that around 524 to 848 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 analyzedThe respective results will be compared with those of a control group that did not receive acupuncture during the observation period
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 analyzedThe respective results will be compared with those of a control group that did not receive acupuncture during the observation period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None