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

Not Applicable

• Conditions: Lymphedema; Breast Cancer

• Registration Number: NCT02517086
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-06-10
• Status Verified: 2015-08
• Study Start: 2015-08
• Primary Completion: 2015-08
• Study First Submitted QC: 2015-08-03
• Last Update Submitted: 2015-08-03
• Study First Posted: 2015-08-06
• Last Update Posted: 2015-08-06
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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