Domiciliary Physiotherapy During Breast Cancer Radiation

Study Overview
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Brief Summary
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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.

Official Title
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Domiciliary Physiotherapy During Breast Cancer Radiation

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: Domiciliary exercises for the upper limbs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Control group (CG) subjected only to evaluations and to no exercises. | |
| Experimental: Study Group<br>Study group (SG) instructed to perform domiciliary exercises for the upper limbs | Other: Domiciliary exercises for the upper limbs<br>* Study group (SG) instructed to perform domiciliary exercises for the upper limbs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gain in range of movement measured in degrees | 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. | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of lymphedema measured in centimeters | 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. | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, physiotherapy, radiotherapy