LymphedemaNCT02475174
Manual Lymphatic Drainage in the Superior Member in Women in Post-surgery for Breast Cancer
A study testing Without upper limb elevation and Upper limb elevation to 30º in people with Lymphedema, run by University of Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Without upper limb elevation and Upper limb elevation to 30º
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Mar 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with axillary lymphadenectomy surgery
- Lymphedema
- Aged 40-60 years.
Who cannot join
- Women with muscle-tendon injury and / or joint injuries member
- Skin disorders
- circulatory diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Blood Circulation Assessment of the Superior Member in Women in Post-surgery for Breast Cancer Submitted to the Manual Lymphatic Drainage
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.
Read the detailed 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).
- Conditions
- Lymphedema
- Being tested
- Without upper limb elevation, Upper limb elevation to 30º
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without upper limb elevationOther
Lymphatic drainage without elevation of the upper limb.
Upper limb elevation to 30ºOther
Lymphatic drainage with elevation of the upper limb to 30º.
| Study group | Role | What they receive |
|---|---|---|
| Without upper limb elevation | Experimental | Manual lymphatic drainage will be held with the voluntary supine without upper limb elevation. Receives: Other: Without upper limb elevation |
| Upper limb elevation to 30º | Experimental | Manual lymphatic drainage will be held with the voluntary supine with the upper limb elevation to 30º. Receives: Other: Upper limb elevation to 30º |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow velocity (Flow velocity in brachial artery and vein)
Flow velocity in brachial and artery vein
Measured: one day
Secondary outcomes (1)
Volume upper limbs
Volume upper limbs
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 posted18 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2015
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475174
- Sponsor's protocol ID
- HCRP nº 13408/2013
- Status last verified
- Jun 2015
- First submitted
- 10 Jun 2015
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Circulation Assessment of the Superior Member in Women in Post-surgery for Breast Cancer Submitted to the Manual Lymphatic Drainage
- ClinicalTrials.gov ID
- NCT02475174
- Acronym / sponsor ID
- HCRP nº 13408/2013
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2016 (estimated)
- First posted
- 18 Jun 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.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without upper limb elevation | Experimental | Other: Without upper limb elevationManual lymphatic drainage will be held with the voluntary supine without upper limb elevation. |
| Upper limb elevation to 30º | Experimental | Other: Upper limb elevation to 30ºManual lymphatic drainage will be held with the voluntary supine with the upper limb elevation to 30º. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with axillary lymphadenectomy surgery
- Lymphedema
- Aged 40-60 years.
Key exclusion criteria (3 listed)
- Women with muscle-tendon injury and / or joint injuries member
- Skin disorders
- circulatory diseases.
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 |
|---|---|---|
| Without upper limb elevationLymphatic drainage without elevation of the upper limb. | Other | Without upper limb elevation |
| Upper limb elevation to 30ºLymphatic drainage with elevation of the upper limb to 30º. | Other | Upper limb elevation to 30º |
Primary outcome
Blood flow velocity (Flow velocity in brachial artery and vein)
Time frame: one day
Flow velocity in brachial and artery vein
1 secondary outcome
Volume upper limbs
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 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.
Questions about this trial
What is this clinical trial studying?
A study testing Without upper limb elevation and Upper limb elevation to 30º in people with 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 3 inclusion and 3 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 18 Jun 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)3315-0215, ecguirro@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow velocity (Flow velocity in brachial artery and vein) (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 18 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.