Breast CancerNCT02517086
Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer
A study testing therapeutic exercises, elastic compression and functional compressive bandaging in people with Breast Cancer and Lymphedema, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- therapeutic exercises, elastic compression and functional compressive bandaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women diagnosed with breast cancer undergoing surgical treatment combined with axillary dissection or sentinel node biopsy
- diagnosed with moderate to severe unilateral lymphedema
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- therapeutic exercises, elastic compression, functional compressive bandaging
- Keywords
- blood circulation
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exercisesOther
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.
elastic compressionOther
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.
functional compressive bandagingOther
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
| Study group | Role | What they receive |
|---|---|---|
| therapeutic exercises | Active comparator | 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. Receives: Other: therapeutic exercises |
| elastic compression | Active comparator | 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. Receives: Other: elastic compression |
| functional compressive bandaging | Active comparator | 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 Receives: Other: functional compressive bandaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2015
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
- Investigators
- Elaine Guirro, Principal investigator, University of Sao Paulo- Ribeirao Preto- Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517086
- Sponsor's protocol ID
- HC-FMRP nº 810616/2014
- Status last verified
- Aug 2015
- First submitted
- 10 Jun 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer
- ClinicalTrials.gov ID
- NCT02517086
- Acronym / sponsor ID
- HC-FMRP nº 810616/2014
- Conditions
- Breast Cancer, Lymphedema
- Keywords
- blood circulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jul 2016 (estimated)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| therapeutic exercises | Active comparator | Other: therapeutic exercisesThe 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 comparator | Other: elastic compressionexercises 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 comparator | Other: functional compressive bandagingexercises 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 |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women diagnosed with breast cancer undergoing surgical treatment combined with axillary dissection or sentinel node biopsy
- diagnosed with moderate to severe unilateral lymphedema
Key exclusion criteria (7 listed)
- Women with muscle-tendon injury and / or joint damage in the -affected limb,
- skin disorders,
- diabetes,
- circulatory disease not controlled, -chemotherapy
- radiotherapy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic exercisesThe 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 |
| elastic compressionexercises 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 |
| functional compressive bandagingexercises 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 |
Primary outcome
Doppler Ultrasound- velocity of blood flow
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Guirro principal investigator
University of Sao Paulo- Ribeirao Preto- Brazil
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic exercises, elastic compression and functional compressive bandaging in people with Breast Cancer and Lymphedema, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elaine Guirro ((16)33150215, ecguirro@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doppler Ultrasound- velocity of blood flow (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.