Domiciliary Physiotherapy During Breast Cancer Radiation

NCT02198118 | Completed DMC

• 2 other identifiers: NCT01940107USP-HCarrara
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

breast cancer; physiotherapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement of lymphedema measured in centimeters

  Three months

Study Arms (2)

Control Group

NO INTERVENTION

Control group (CG) subjected only to evaluations and to no exercises.

Study Group

EXPERIMENTAL

Study group (SG) instructed to perform domiciliary exercises for the upper limbs

Other: Domiciliary exercises for the upper limbs

Interventions

Domiciliary exercises for the upper limbs OTHER

Study group (SG) instructed to perform domiciliary exercises for the upper limbs.

Study Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

Related Publications (1)

• Leal NF, Oliveira HF, Carrara HH. Supervised physical therapy in women treated with radiotherapy for breast cancer. Rev Lat Am Enfermagem. 2016 Aug 15;24:e2755. doi: 10.1590/1518-8345.0702.2755.

  PMID: 27533265 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Breast Neoplasms

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nara FB Leal, Master

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 23, 2014
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

BR (1)