Domiciliary Physiotherapy During Breast Cancer Radiation
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.
|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|
- 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.
- 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.
|Study Start Date:||January 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02198118
|Hospital das Clínicas de Ribeirão Preto|
|Ribeirão Preto, SP, Brazil, 14048900|
|Study Chair:||Nara FB Leal, Master||University of Sao Paulo|