Domiciliary Physiotherapy During Breast Cancer Radiation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helio Carrara, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02198118
First received: July 18, 2014
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

Background: Breast cancer is the most common type of cancer among women. Its treatment, including radiotherapy (RT), can cause potential complications to be treated by the physiotherapy. Objective: To evaluate 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. Study design: This is a prospective randomized controlled clinical trial. Methods: Thirty six volunteers were recruited from November 2009 to March 2012 and they were appraised at three different times: pre-RT, post-RT and 2 months after the end of RT. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. They were divided into two groups: CG) control group, submitted only to the assessments and SG) study group, submitted to domiciliary physiotherapy.


Condition Intervention
Shoulder Pain
Other: Domiciliary exercises for the upper limbs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Domiciliary Physiotherapy During Breast Cancer Radiation

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Gain in range of movement measured in degrees [ Time Frame: Three months ] [ Designated as safety issue: No ]
    The volunteers were evaluated at three distinct times: pre-RT (first evaluation), post-RT (second evaluation) and 2 months after the end of RT (third evaluation). The following parameters were evaluated: ROM of shoulder joint and upper limb perimetry. To assess shoulder ROM, the movements of flexion, extension, abduction, adduction, internal rotation and external rotation were measured, with each movement being performed by subjects. The volunteers were randomly divided into 2 groups: a control group (CG) subjected only to evaluations and to no exercise, and a study group (SG) instructed to perform domiciliary exercises for the upper limbs. The plan randomization was performed by a computer program that generated a list with the allotment of cases to the two groups. The allocation was randomized, but not concealed.


Secondary Outcome Measures:
  • Improvement of lymphedema measured in centimeters [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Lymphedema was evaluated during the period of the study through perimetry measurements that were made at 6 different points: point A -metacarpophalangeal joint of the 2nd, 3rd, 4th and 5th fingers; point B - an imaginary line passing through the metacarpophalangeal joint of the thumb; point C - 10 cm below the olecranon; point D - 6 cm below the olecranon; point E - 6 cm above the olecranon, and point F - 10 cm above the olecranon 20. The volunteer should be sitting, with her arm resting on her thigh and the forearm supinated. The measurements were bilateral and carried out by the same observer.


Enrollment: 36
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Control group (CG) subjected only to evaluations and to no exercises.
Experimental: Study Group
Study group (SG) instructed to perform domiciliary exercises for the upper limbs
Other: Domiciliary exercises for the upper limbs
Study group (SG) instructed to perform domiciliary exercises for the upper limbs.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Having been diagnosed with unilateral breast cancer and having been submitted to surgical and radiation treatment as part of the treatment for breast cancer, according to the therapeutic protocol of the unit

Exclusion Criteria:

- Patients with neurological or orthopedic diseases that could impair the movements of the upper limbs, bilateral breast cancer, previous thoracic radiotherapy, and the presence of distant metastasis.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02198118

Locations
Brazil
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, SP, Brazil, 14048900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Nara FB Leal, Master University of Sao Paulo
  More Information

No publications provided

Responsible Party: Helio Carrara, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02198118     History of Changes
Other Study ID Numbers: NCT01940107, USP-HCarrara
Study First Received: July 18, 2014
Last Updated: July 22, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
breast cancer
physiotherapy
radiotherapy

Additional relevant MeSH terms:
Shoulder Pain
Breast Neoplasms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014