Manual Lymphatic Drainage in the Superior Member in Women in Post-surgery for Breast Cancer

June 15, 2015 updated by: Elaine Caldeira de Oliveira Guirro, University of Sao Paulo

Blood Circulation Assessment of the Superior Member in Women in Post-surgery for Breast Cancer Submitted to the Manual Lymphatic Drainage

Evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy breast cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy breast cancer. Will be evaluated 30 volunteers aged between 40 and 60 years, divided into 2 equal groups, submitted at MLD: Group 1 - volunteers who underwent surgery for breast cancer that have lymphedema, subject to manual lymphatic drainage without upper limb elevation; Group 2 - volunteers who underwent surgery for breast cancer that have lymphedema, subject to manual lymphatic drainage with the upper limb elevation to 30º. Data will be collected by ultrasound Doppler in vein and brachial artery before, after MLD, immediately after, and 30 minutes after therapeutic treatment, with and without elevation of 30°, cross over delimitation, being made a therapy session for therapeutic use with and without elevation, with interval period (washout) for seven days. The order of treatment protocols will be randomized by simple raffle for each volunteer. The data within and between groups will be evaluated by a statistical test t student or ANOVA. Otherwise it will be used Kruskal-Wallis followed test by Dunn. Data processing will be performed by software and fixed the critical level of 5% (p<0,05).

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with axillary lymphadenectomy surgery
  • Lymphedema
  • Aged 40-60 years.

Exclusion Criteria:

  • Women with muscle-tendon injury and / or joint injuries member
  • Skin disorders
  • circulatory diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Without upper limb elevation
Manual lymphatic drainage will be held with the voluntary supine without upper limb elevation.
Other: Without upper limb elevation
Lymphatic drainage without elevation of the upper limb.
Experimental: Upper limb elevation to 30º
Manual lymphatic drainage will be held with the voluntary supine with the upper limb elevation to 30º.
Other: Upper limb elevation to 30º
Lymphatic drainage with elevation of the upper limb to 30º.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow velocity (Flow velocity in brachial artery and vein)
Time Frame: one day
Flow velocity in brachial and artery vein
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume upper limbs
Time Frame: one day
Volume upper limbs
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCRP nº 13408/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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