Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer
1 other identifier
interventional
3
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Aug 2015
Shorter than P25 for not_applicable breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 6, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 6, 2015
August 1, 2015
Same day
June 10, 2015
August 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
therapeutic exercises
ACTIVE COMPARATORThe 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.
elastic compression
ACTIVE COMPARATORexercises 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.
functional compressive bandaging
ACTIVE COMPARATORexercises 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
Interventions
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.
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.
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
Eligibility Criteria
You may qualify if:
- women diagnosed with breast cancer undergoing surgical treatment combined with axillary dissection or sentinel node biopsy
- diagnosed with moderate to severe unilateral lymphedema
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elaine Guirro
University of Sao Paulo- Ribeirao Preto- Brazil
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Monique Silva Rezende
Study Record Dates
First Submitted
June 10, 2015
First Posted
August 6, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2015
Study Completion
July 1, 2016
Last Updated
August 6, 2015
Record last verified: 2015-08