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

Primary Purpose

Lymphedema

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Without upper limb elevation
Upper limb elevation to 30º
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Without upper limb elevation

    Upper limb elevation to 30º

    Arm Description

    Manual lymphatic drainage will be held with the voluntary supine without upper limb elevation.

    Manual lymphatic drainage will be held with the voluntary supine with the upper limb elevation to 30º.

    Outcomes

    Primary Outcome Measures

    Blood flow velocity (Flow velocity in brachial artery and vein)
    Flow velocity in brachial and artery vein

    Secondary Outcome Measures

    Volume upper limbs
    Volume upper limbs

    Full Information

    First Posted
    June 10, 2015
    Last Updated
    June 15, 2015
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02475174
    Brief Title
    Manual Lymphatic Drainage in the Superior Member in Women in Post-surgery for Breast Cancer
    Official Title
    Blood Circulation Assessment of the Superior Member in Women in Post-surgery for Breast Cancer Submitted to the Manual Lymphatic Drainage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    March 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphedema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Without upper limb elevation
    Arm Type
    Experimental
    Arm Description
    Manual lymphatic drainage will be held with the voluntary supine without upper limb elevation.
    Arm Title
    Upper limb elevation to 30º
    Arm Type
    Experimental
    Arm Description
    Manual lymphatic drainage will be held with the voluntary supine with the upper limb elevation to 30º.
    Intervention Type
    Other
    Intervention Name(s)
    Without upper limb elevation
    Intervention Description
    Lymphatic drainage without elevation of the upper limb.
    Intervention Type
    Other
    Intervention Name(s)
    Upper limb elevation to 30º
    Intervention Description
    Lymphatic drainage with elevation of the upper limb to 30º.
    Primary Outcome Measure Information:
    Title
    Blood flow velocity (Flow velocity in brachial artery and vein)
    Description
    Flow velocity in brachial and artery vein
    Time Frame
    one day
    Secondary Outcome Measure Information:
    Title
    Volume upper limbs
    Description
    Volume upper limbs
    Time Frame
    one day

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elaine Guirro
    Phone
    (16)3315-0215
    Email
    ecguirro@fmrp.usp.br
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lais Neves
    Phone
    (16) 3315-0215
    Email
    laisneves@usp.br

    12. IPD Sharing Statement

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

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