ClinicalTrials.gov
ClinicalTrials.gov Menu

Domiciliary Physiotherapy During Breast Cancer Radiation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02198118
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Helio Carrara, University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Shoulder Pain Other: Domiciliary exercises for the upper limbs Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Domiciliary Physiotherapy During Breast Cancer Radiation
Study Start Date : January 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Gain in range of movement measured in degrees [ Time Frame: Three months ]
    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 :
  1. Improvement of lymphedema measured in centimeters [ Time Frame: Three months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes 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.


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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helio Carrara, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02198118     History of Changes
Other Study ID Numbers: USP-HCarrara ( Other Identifier: University of São Paulo )
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014

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

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