Effectiveness and Safety of Acupuncture for Climacteric Syndrome in Patients With Breast Cancer
NCT ID: NCT01275807
Last Updated: 2015-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
190 participants
INTERVENTIONAL
2010-03-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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acupuncture
10 acupuncture sessions
acupuncture
10 sessions of acupuncture
self care
psychological support, phisical exercice, diet, self care groups
self care
physical exercice, diet, self help groups, psychological support
Interventions
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acupuncture
10 sessions of acupuncture
self care
physical exercice, diet, self help groups, psychological support
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* other systemic treatments for climateric syndrome (tibolone, antidepressants, homeopathy)
* chemotherapy or radiotherapy
* patients who refuses acupuncture
18 Years
65 Years
FEMALE
No
Sponsors
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Regione Emilia-Romagna
OTHER
Azienda Usl di Bologna
OTHER_GOV
Responsible Party
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Principal Investigators
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grazia lesi, MD
Role: STUDY_DIRECTOR
Bologna Local Health District - Azienda Usl di Bologna
Locations
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Unità operativa (U.O.) salute donna infanzia e adolescenza e Unità operativa Consultori
Bologna, Bologna, Italy
Oncologic Medicine, Carpi Hospital
Carpi, Modena, Italy
Dipartimento Anestesia, rianimazione, terapia del dolore e comparto operatorio,
Piacenza, , Italy
U.O. Medicina Oncologica - Ospedale Santa Maria Nuova Reggio Emilia
Reggio Emilia, , Italy
Countries
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References
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Gupta P, Sturdee DW, Palin SL, Majumder K, Fear R, Marshall T, Paterson I. Menopausal symptoms in women treated for breast cancer: the prevalence and severity of symptoms and their perceived effects on quality of life. Climacteric. 2006 Feb;9(1):49-58. doi: 10.1080/13697130500487224.
Lesi G, Razzini G, Musti MA, Stivanello E, Petrucci C, Benedetti B, Rondini E, Ligabue MB, Scaltriti L, Botti A, Artioli F, Mancuso P, Cardini F, Pandolfi P. Acupuncture As an Integrative Approach for the Treatment of Hot Flashes in Women With Breast Cancer: A Prospective Multicenter Randomized Controlled Trial (AcCliMaT). J Clin Oncol. 2016 May 20;34(15):1795-802. doi: 10.1200/JCO.2015.63.2893. Epub 2016 Mar 28.
Other Identifiers
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DGR-2025/2008-Lesi
Identifier Type: -
Identifier Source: org_study_id
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