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

September 21, 2015 updated by: Azienda Usl di Bologna

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

190

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40100
        • Unità operativa (U.O.) salute donna infanzia e adolescenza e Unità operativa Consultori
      • Piacenza, Italy
        • Dipartimento Anestesia, rianimazione, terapia del dolore e comparto operatorio,
      • Reggio Emilia, Italy
        • U.O. Medicina Oncologica - Ospedale Santa Maria Nuova Reggio Emilia
    • Modena
      • Carpi, Modena, Italy
        • Oncologic Medicine, Carpi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acupuncture
10 acupuncture sessions
Device: acupuncture
10 sessions of acupuncture
Other Names:
  • 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 Names:
  • self help

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Usl di Bologna

Collaborators

Regione Emilia-Romagna

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 30, 2010

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGR-2025/2008-Lesi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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