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

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ClinicalTrials.gov Identifier: NCT01275807
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
Regione Emilia-Romagna
Information provided by (Responsible Party):
Azienda Usl di Bologna

Brief Summary:
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 or disease Intervention/treatment Phase
Climacteric Syndrome Device: acupuncture Other: self care Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2010
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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. ]
    Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275807


Locations
Italy
Oncologic Medicine, Carpi Hospital
Carpi, Modena, Italy
Unità operativa (U.O.) salute donna infanzia e adolescenza e Unità operativa Consultori
Bologna, Italy, 40100
Dipartimento Anestesia, rianimazione, terapia del dolore e comparto operatorio,
Piacenza, Italy
U.O. Medicina Oncologica - Ospedale Santa Maria Nuova Reggio Emilia
Reggio Emilia, Italy
Sponsors and Collaborators
Azienda Usl di Bologna
Regione Emilia-Romagna
Investigators
Study Director: grazia lesi, MD Bologna Local Health District - Azienda Usl di Bologna

Publications:
Responsible Party: Azienda Usl di Bologna
ClinicalTrials.gov Identifier: NCT01275807     History of Changes
Other Study ID Numbers: DGR-2025/2008-Lesi
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes