Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer

The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Lymphedema
• Intervention / Treatment: Other: therapeutic exercises; Other: elastic compression; Other: functional compressive bandaging

Detailed Description

With increasing survival of women treated for breast cancer, it becomes necessary to evaluate the effect of therapeutic resources in morbidity due to surgical treatment of breast cancer. The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer. The study will be conducted according to design random cross over and wash out period of 7 days. They will be evaluated 30 volunteers aged between 45 and 70 years, submitted to treatment of breast cancer. The volunteers will be submitted to three different therapeutic procedures applied randomly by lot: active exercises, functional compressive bandaging with active exercises and elastic compression with active exercises. The profile of blood flow, including speed and direction, will be assessed by Doppler ultrasound before and after, at 0, 15, 30 minutes. Normality will be verified by the Shapiro-Wilk test, and the effect of behavior between pre- and post-intervention will be evaluated by ANOVA two-way followed by post-hoc test Friedman followed rank, p <0.05 . The data obtained in the study are intended to enhance the forms of physical therapy intervention in the face of circulatory morbidities resulting from breast cancer treatments.

• Study Type: Interventional
• Enrollment (Anticipated): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elaine Guirro; Phone Number: (16)33150215; Email: ecguirro@fmrp.usp.br
• Study Contact Backup: Name: Monique Rezende; Phone Number: (16)33150215; Email: monique_rezende@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women diagnosed with breast cancer undergoing surgical treatment combined with axillary dissection or sentinel node biopsy
• diagnosed with moderate to severe unilateral lymphedema

Exclusion Criteria:

• Women with muscle-tendon injury and / or joint damage in the -affected limb,
• skin disorders,
• diabetes,
• circulatory disease not controlled, -chemotherapy
• radiotherapy,
• diagnostic with metastasis in the upper limb
• women pregnancy.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: therapeutic exercises; The applied therapeutic exercises involve shoulder movements including flexion, extension, abduction, adduction, internal and external rotation in isolated or combined movements, with ten repetitions of each movement, associated with the music, and stretching movements finalizing the sequence of movements.	Other: therapeutic exercises; The applied therapeutic exercises involve shoulder movements including flexion, extension, abduction, adduction, internal and external rotation in isolated or combined movements, with ten repetitions of each movement, associated with the music, and stretching movements finalizing the sequence of movements.
Active Comparator: elastic compression; exercises for upper limb will be performed for an hour associated with the use of elastic compression. Elastic compression will be effected through a clamp brand compression of 30-40 mmHg according to the measures of voluntary member.	Other: elastic compression; exercises for upper limb will be performed for an hour associated with the use of elastic compression. Elastic compression will be effected through a clamp brand compression of 30-40 mmHg according to the measures of voluntary member.
Active Comparator: functional compressive bandaging; exercises for upper limb will be performed for an hour associated with the use of functional compressive bandaging. The functional compressive bandaging will be held with the volunteer sitting with ipsilateral upper limb resting on the support surgery. After hydration member a cotton mesh is used to prevent friction density 1cm strip of foam on the member to be wrapped. Elastic bandages of cotton will be involved 5 cm, 10 cm, 15 cm from the fingers to the axillary region multilayered	Other: functional compressive bandaging; exercises for upper limb will be performed for an hour associated with the use of functional compressive bandaging. The functional compressive bandaging will be held with the volunteer sitting with ipsilateral upper limb resting on the support surgery. After hydration member a cotton mesh is used to prevent friction density 1cm strip of foam on the member to be wrapped. Elastic bandages of cotton will be involved 5 cm, 10 cm, 15 cm from the fingers to the axillary region multilayered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Doppler Ultrasound- velocity of blood flow	Doppler ultrasound is used to measure the velocity of blood flow of the axillary and brachial vein of the upper limb with lymphedema	one day

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Elaine Guirro, University of Sao Paulo- Ribeirao Preto- Brazil

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (Estimate): August 6, 2015

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: blood circulation
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: HC-FMRP nº 810616/2014