Domiciliary Physiotherapy During Breast Cancer Radiation

Shoulder Pain Clinical Trial

Official title:

Domiciliary Physiotherapy During Breast Cancer Radiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198118
• Other study ID #: NCT01940107
• Secondary ID: USP-HCarrara
• Status: Completed
• Phase: N/A
• First received: July 18, 2014
• Last updated: July 22, 2014
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Domiciliary exercises for the upper limbs
Study group (SG) instructed to perform domiciliary exercises for the upper limbs.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas de Ribeirão Preto	Ribeirão Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No