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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02475174
• Other study ID #: HCRP nº 13408/2013
• Status: Not yet recruiting
• Phase: N/A
• First received: June 10, 2015
• Last updated: June 15, 2015
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2015
• Source: University of Sao Paulo
• Contact: Elaine Guirro
• Phone: (16)3315-0215
• Email: ecguirro[@]fmrp.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema

Intervention

Other:
• Without upper limb elevation
Lymphatic drainage without elevation of the upper limb.
• Upper limb elevation to 30º
Lymphatic drainage with elevation of the upper limb to 30º.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood flow velocity (Flow velocity in brachial artery and vein)	Flow velocity in brachial and artery vein	one day	No
Secondary	Volume upper limbs	Volume upper limbs	one day	No