Treatment of Hot Flushes in Breast Cancer Patients With Acupuncture

Study Overview
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Brief Summary
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In a randomized 3-group clinical study acupuncture is used for the relief of menopausal hot flushes and sleep disturbances in women treated for breastcancer. The three groups consists of 35 women given acupuncture once a week five times and 35 women given shamacupuncture once a week five times and 35 women with no kind of treatment. Se-estradiol and endorphin is measured before and after the acupuncture. We want to state that acupuncture given five times once a week has a significant better effect on hot flushes and sleeping disturbances than shamacupuncture or no treatment at all. We also want to measure if there are any changes in se-estradiol and endorphine

Detailed Description
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Breast cancer patients often have a higher prevalance of menopausal symptoms with hor flushes and sleeping disturbances than women in the general population, and hormone replacement therapy is not considered suitable for breast cancer patients because an increase in oestrogen is contraindicated. There has been some evidence that acupuncture is suitable treatment for hot flushes and therefore we had a small pilotproject where 25 women treated for breast cancer were given a course of classical body acupuncture with one 15 min treatment session per week for 5 weeks. The effekt was remarkable. We want to prove if this effekt is significantly better than shamacupuncture or to no treatment at all. This is a prospective, randomized and doubbleblinded study: 35 women get classical body acupuncture once a week 5 times 35 women get shamacupuncture once a week 5 times 35 women get no acupuncture. Se-estradiol and se-endorphine will be measure before start of the first acupuncture and after the first and fifth acupuncture. The women with no treatment will have blodsamples too in the beginning and at the end of the fifth week.

Conditions
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Breast Cancer, Postmenopause

Intervention / Treatment
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* Device: acupuncture
* Device: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women older than 35 years treated for breastcancer having hot flushes and sleeping disturbances.It is not allowed to take estrogen as tablets or plaster. Exclusion Criteria: Failing to give consent Any use of estrogen as tablets or plaster

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real acupuncture<br> | Device: acupuncture<br> <br> * Other names: Acupuncture, hot flushes;|
| Sham Comparator: Sham acupuncture<br> | Device: Sham acupuncture<br> <br> |
| No Intervention: No intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| using a hot flushes rating scale. |  | 12 weeks | 
| Sleep disturbances yes or no |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring se-estrogen and se-endorhine before and after acupuncture |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Acupuncture, Post-menopausal hot flushes, Se-estradiol, Se-endorphine