Domiciliary Physiotherapy During Breast Cancer Radiation

NCT ID: NCT02198118

Last Updated: 2014-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Study Group

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

Group Type EXPERIMENTAL

Domiciliary exercises for the upper limbs

Intervention Type OTHER

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

Interventions

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Domiciliary exercises for the upper limbs

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

Intervention Type OTHER

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Helio Carrara

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nara FB Leal, Master

Role: STUDY_CHAIR

University of Sao Paulo

Locations

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Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 27533265 (View on PubMed)

Other Identifiers

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USP-HCarrara

Identifier Type: OTHER

Identifier Source: secondary_id

NCT01940107

Identifier Type: -

Identifier Source: org_study_id

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