Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.

Detailed Description
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The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer. Hormonal therapy is one of the most common treatments for breast cancer in women. Unfortunately, many women on hormonal therapy suffer from hot flashes (the sudden sensation of heat throughout the face, neck and chest, with or without shivering and sweating). Many medicines have been used to treat hot flashes, but no single medication has been found to work reliably. Acupuncture has been shown to be effective for many conditions in Western medicine specifically for dry mouth in people who have received radiation to their head and neck, as well as for hot flashes in women during menopause (the change of life). In this study, we are investigating whether acupuncture is effective for women suffering hot flashes that result from their treatment of breast cancer.

Official Title
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Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Acupuncture
* Procedure: Sham acupuncture therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18 years of age or older History of breast cancer who have received hormonal therapy Personal history of hot flashes Patients will be accepted if receiving therapy with traditional allopathic medicines if their hot flashes have persisted after two months Exclusion Criteria: Receiving therapy with traditional allopathic medicines for hot flashes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham acupuncture therapy<br>Sham acupuncture therapy | Procedure: Sham acupuncture therapy<br>* Sham procedure will be insertion of 5 needles for 20 minutes provided twice during first week, then once per week thereafter.<br>|
| Active Comparator: Acupuncture<br>Acupuncture | Procedure: Acupuncture<br>* Acupuncture using enhanced Ming Men technique for 20 minutes, twice during 1st week, then once during week 2, 3,and 4.<br>|
| No Intervention: Observation<br>Observation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define efficacy of acupuncture to points of the enhanced Ming Men technique for relief of hot flashes after hormonal therapy for breast cancer. |  | weekly evaluation up to 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer