Effectiveness and Safety of Acupuncture for Climacteric Syndrome in Patients With Breast Cancer

Study Overview
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Brief Summary
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The purpose of the investigators study is to create the evidence of effectivness on climacteric syndrome in patients affected by breast cancer, by acupuncture added to the standard care (self care).

Detailed Description
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The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: Greene climacteric scale score, quality of life (MenQol italian version), overall improvement in climacteric syndrome, adverse effects from treatment.

Official Title
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Acupuncture as an Integrated Intervention for the Control of Symptoms of Climacteric Syndrome in Patients Affected by Breast Cancer

Conditions
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Climacteric Syndrome

Intervention / Treatment
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* Device: acupuncture
* Other: self care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: breast cancer thermoregulation symptoms from at least 6-8 weeks - at least 6 hot flushes a day climateric simptoms age from 18 to 65 years spontaneous or caused by chemotherapy amenorrea hormone therapy for breast cancer Green climateric scale score = or > of 15 performance status Eastern Cooperative Oncology Group (ECOG) < or = to 1 the patient agrees to follow physical exercice diet and self-help groups Exclusion Criteria: Hormone substitutive Therapy (TOS) during the last month other systemic treatments for climateric syndrome (tibolone, antidepressants, homeopathy) chemotherapy or radiotherapy patients who refuses acupuncture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br>10 acupuncture sessions | Device: acupuncture<br>* 10 sessions of acupuncture<br>* Other names: chinese traditional medicine;|
| Active Comparator: self care<br>psychological support, phisical exercice, diet, self care groups | Other: self care<br>* physical exercice, diet, self help groups, psychological support<br>* Other names: self help;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Greene climacteric scale | Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes. | baseline ( 14 days before randomization) , between the 5th and 6th session af acupunture(only for experimental arm) at 14 weeks after randomization and at 3 and at 6 month after randomization for both arms. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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climacteric, climacteric syndrome