Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation

September 10, 2013 updated by: Helio Carrara, University of Sao Paulo
To observe the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was significant difference between the ipsilateral and contralateral limbs for flexion, abduction and external rotation. There was no difference in perimetry in either group

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

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

  • Brazil
    • Saõ Paulo
      • Ribeirão Preto, Saõ Paulo, Brazil, 14049900
        • Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • be diagnosed with unilateral breast cancer;
  • be submitted to surgical and radiation treatment as part of the treatment for breast cancer.

Exclusion Criteria:

  • patients with neurological or orthopedic diseases that could impair the upper limb movements
  • bilateral breast cancer;
  • prior thoracic radiotherapy;
  • presence of distant metastasis.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group (CG)
Control Group, which were subjected only to evaluations and to no exercise
Other: evaluations
Only evaluations
Experimental: Study Group (SG)
Study group (SG), was oriented to perform domiciliary exercises for the upper limbs.
Procedure: Protocol of physiotherapy exercises
Oriented domiciliary physiotherapeutic exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recovery of shoulder range of movements (ROM) and prevention of arm lymphedema
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

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

August 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hhacarra

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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