NCT01940107

Brief Summary

To observe 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. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was significant difference between the ipsilateral and contralateral limbs for flexion, abduction and external rotation. There was no difference in perimetry in either group

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2013

Enrollment Period

1.9 years

First QC Date

September 6, 2013

Last Update Submit

September 10, 2013

Conditions

Keywords

breast cancer,radiotherapy,physical therapy,upper limb

Outcome Measures

Primary Outcomes (1)

  • Recovery of shoulder range of movements (ROM) and prevention of arm lymphedema

    90 days

Study Arms (2)

Control Group (CG)

OTHER

Control Group, which were subjected only to evaluations and to no exercise

Other: evaluations

Study Group (SG)

EXPERIMENTAL

Study group (SG), was oriented to perform domiciliary exercises for the upper limbs.

Procedure: Protocol of physiotherapy exercises

Interventions

Only evaluations

Control Group (CG)

Oriented domiciliary physiotherapeutic exercises

Study Group (SG)

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be diagnosed with unilateral breast cancer;
  • be submitted to surgical and radiation treatment as part of the treatment for breast cancer.

You may not qualify if:

  • patients with neurological or orthopedic diseases that could impair the upper limb movements
  • bilateral breast cancer;
  • prior thoracic radiotherapy;
  • presence of distant metastasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, Saõ Paulo, 14049900, Brazil

Location

MeSH Terms

Conditions

BursitisShoulder PainBreast Neoplasms

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 11, 2013

Study Start

August 1, 2010

Primary Completion

July 1, 2012

Study Completion

September 1, 2012

Last Updated

September 11, 2013

Record last verified: 2013-09

Locations