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

This study is currently recruiting participants.
Verified January 2011 by Azienda Usl di Bologna
Sponsor:
Collaborator:
Emilia-Romagna District
Information provided by:
Azienda Usl di Bologna
ClinicalTrials.gov Identifier:
NCT01275807
First received: December 30, 2010
Last updated: January 12, 2011
Last verified: January 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Menopausal Syndrome
 Device: acupuncture
Other: self care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture as an Integrated Intervention for the Control of Symptoms of Climacteric Syndrome in Patients Affected by Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Usl di Bologna:

Primary Outcome Measures:
  • Greene climacteric scale [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes.


Estimated Enrollment: 210
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupuncture
10 acupuncture sessions
 Device: acupuncture
10 sessions of acupuncture
Other Name: chinese traditional medicine
Active Comparator: self care
psychological support, phisical exercice, diet, self care groups
 Other: self care
physical exercice, diet, self help groups, psychological support
Other Name: self help

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275807

Contacts
Contact: grazia lesi, MD ++39-051-2869204 grazia.lesi@ausl.bo.it

Locations
Italy
Oncologic Medicine, Carpi Hospital Recruiting
Carpi, Modena, Italy
Contact: F. Artioli, MD         g.razzini@ausl.mo.it    
Contact         r.guerzoni@ausl.mo.it    
Unità operativa (U.O.) salute donna infanzia e adolescenza e Unità operativa Consultori Recruiting
Bologna, Italy, 40100
Contact: grazia lesi, MD     ++39-051-2869204     grazia.lesi@ausl.bo.it    
Principal Investigator: grazia lesi, MD            
Dipartimento Anestesia, rianimazione, terapia del dolore e comparto operatorio, Recruiting
Piacenza, Italy
Contact: Alberto Botti            
U.O. Medicina Oncologica - Ospedale Santa Maria Nuova Reggio Emilia Recruiting
Reggio Emilia, Italy
Contact         ligabuem@ausl.re.it    
Sponsors and Collaborators
Azienda Usl di Bologna
Emilia-Romagna District
Investigators
Study Director: grazia lesi, MD Bologna Local Health District - Azienda Usl di Bologna
  More Information

Publications:

Responsible Party: Bologna Local Health District - Azienda Unità sanitaria locale (Usl) di Bologna - Lesi Grazia, Bologna Local Health District - Azienda Usl di Bologna
ClinicalTrials.gov Identifier: NCT01275807     History of Changes
Other Study ID Numbers: DGR-2025/2008-Lesi
Study First Received: December 30, 2010
Last Updated: January 12, 2011
Health Authority: Italy: Ethics Committee
United States: Federal Government

Keywords provided by Azienda Usl di Bologna:
climacteric, climacteric syndrome

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 18, 2012