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

This study has been completed.
Regione Emilia-Romagna
Information provided by (Responsible Party):
Azienda Usl di Bologna Identifier:
First received: December 30, 2010
Last updated: September 21, 2015
Last verified: September 2015
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
Climacteric Syndrome
Device: acupuncture
Other: self care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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. ]
    Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes.

Enrollment: 190
Study Start Date: March 2010
Study Completion Date: September 2015
Primary Completion Date: September 2015 (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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01275807

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
Study Director: grazia lesi, MD Bologna Local Health District - Azienda Usl di Bologna
  More Information

Responsible Party: Azienda Usl di Bologna Identifier: NCT01275807     History of Changes
Other Study ID Numbers: DGR-2025/2008-Lesi
Study First Received: December 30, 2010
Last Updated: September 21, 2015

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

Additional relevant MeSH terms:
Pathologic Processes processed this record on April 28, 2017