Breast CancerNCT01893957
Effects of Electrical Stimulation on Blood Circulation and Sensibility Tactil in Lymphadenectomy
A study testing high voltage electrical stimulation - axillary lymphadenectomy, High voltage electrical stimulation - ( healthy women ) and Neurodyn High Volt Model (IBRAMED) in people with Breast Cancer, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to investigate the influence of electrical stimulation at the speed of blood circulation and tactile sensitivity of the arms of women who underwent axillary dissection for breast cancer. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- high voltage electrical stimulation - axillary lymphadenectomy, High voltage electrical stimulation - ( healthy women ) and Neurodyn High Volt Model (IBRAMED)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Sep 2013
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- women, 40 to 60 years old, with abnormal sensitivity of the ipsilateral upper limb due to Type Madden Modified Radical Mastectomy for breast cancer with axillary lymphadenectomy
Who cannot join
- patients undergoing other types of surgery that is not considered in the inclusion criteria, bilateral mastectomy, has a diagnosis of metastases, and skin disorders such as ulcers or erysipelas in the region (or nearby) the intercostal nerve pathway. We also excluded volunteers with some sort of cognitive impairment
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Medical School of Ribeirão Preto
Ribeirão Preto, São Paulo, 14049-900
Elaine C Guirro, Ph. D, 551636024584, ecguirro@fmrp.usp.br
About this study
Official title: Evaluation of the Effects of High Voltage Electrical Stimulation in the Floe Blood and Tactile Sensitivity of Women Undergoing Axillary Lymphadenectomy
The aim of this study is to investigate the influence of electrical stimulation at the speed of blood circulation and tactile sensitivity of the arms of women who underwent axillary dissection for breast cancer.
Read the detailed description
Introduction: the surgical treatment of breast cancer, especially axillary lymphadenectomy (AL), can cause blood circulatory changes, also partial or total lesion of the sensory nerve intercostobrachial, often causing anesthesia or hypoesthesia in the corresponding dermatome ipsilateral upper limb surgery. Objective: to investigate the influence of high voltage electrical stimulation (HVES) in the in the blood flow and tactile sensitivity in nerve path intercostobrachial of women undergoing AL. Methodology: sample of 30 volunteers, aged between 40 and 60 years, divided into two equal groups (n = 15): women with axillary dissection for breast cancer undergoing therapeutic procedure (GAL) and control group (CG) composed of women who did not undergoing axillary surgery. The treatment procedure consist of the application of high voltage electrical simulation for 30 minutes in both limbs twice a week over the course of seven weeks. The profile of blood flow, including speed, direction were evaluated by means of continuous wave Doppler ultrasound. The assessment of tactile sensitivity was accomplished through esthesiometer in three stages: before the start of the first therapeutic procedure, after completion of the intervention and 30 days after the end of treatment (wash-out). The data will be analyzed using descriptive statistics (ANOVA) even as the hypothesis testing of Shapiro-Wilk and if the data are not normally distributed, non-parametric tests will be used. For the analyses will be used SPSS software with critical level of 5%. The results obtained on this study aim to justify therapies for intervention with that equipment in the treatment of morbidities caused by axillary linfadenectomy.
- Conditions
- Breast Cancer
- Being tested
- high voltage electrical stimulation - axillary lymphadenectomy, High voltage electrical stimulation - ( healthy women ), Neurodyn High Volt Model (IBRAMED)
- Keywords
- breast cancer, physical therapy, electrical stimulation, tactile sensitivity, flow blood
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high voltage electrical stimulation - axillary lymphadenectomyProcedure or surgery
Will be used high voltage electrical stimulation, Neurodyn High Volt Model (IBRAMED), twice a week, over the course of seven weeks,in 20-minute sessions on alternate days. The parameters are: high voltage pulsed current, monopolar (cathode), 100 Hz, synchronized mode, on/off relationship of 3:9 seconds, rise/decay 2:1 seconds, and motor threshold. The electrodes are positioned in the middle and distal thirds of the anterior surface of the forearm and arm.
High voltage electrical stimulation - ( healthy women )Procedure or surgery
Will be used high voltage electrical stimulation, Neurodyn High Volt Model (IBRAMED), twice a week, over the course of seven weeks,in 20-minute sessions on alternate days. The parameters are: high voltage pulsed current, monopolar (cathode), 100 Hz, synchronized mode, on/off relationship of 3:9 seconds, rise/decay 2:1 seconds, and motor threshold. The electrodes are positioned in the middle and distal thirds of the anterior surface of the forearm and arm.
Neurodyn High Volt Model (IBRAMED)Device
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Healthy women undergoing high voltage electrical stimulation Receives: Procedure: High voltage electrical stimulation - ( healthy women ); Device: Neurodyn High Volt Model (IBRAMED) |
| Axillary lymphadenectomy | Experimental | Axillary lymphadenectomy volunteers undergoing to high voltage electrical stimulation Receives: Procedure: high voltage electrical stimulation - axillary lymphadenectomy; Device: Neurodyn High Volt Model (IBRAMED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tactile sensitivity
Will be used Estesiômetro Semmes-Weinstein (SORRY®) to evaluate the tactile sensibility in dermatomes corresponding on the medial and superior-posterior arm.
Measured: 2 years
Secondary outcomes (1)
Blood flow velocity
The evaluation of the peripheral arterial and venous flow in the upper limbs will be accomplished through the equipment ultrasound Doppler (Nicolet Vascular Versalab SE®), and the collection site will be in the antecubital fossa, of the brachial artery and brachial vein.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startAug 2012
- Primary completionJul 2013 (estimated)
- Study completionSep 2013 (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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- NCT01893957
- Sponsor's protocol ID
- U1111-1143-1024
- Status last verified
- Jul 2013
- First submitted
- 21 Jun 2013
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of High Voltage Electrical Stimulation in the Floe Blood and Tactile Sensitivity of Women Undergoing Axillary Lymphadenectomy
- ClinicalTrials.gov ID
- NCT01893957
- Acronym / sponsor ID
- U1111-1143-1024
- Conditions
- Breast Cancer
- Keywords
- breast cancer, physical therapy, electrical stimulation, tactile sensitivity, flow blood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 9 Jul 2013 (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 aim of this study is to investigate the influence of electrical stimulation at the speed of blood circulation and tactile sensitivity of the arms of women who underwent axillary dissection for breast cancer.
Detailed description
Introduction: the surgical treatment of breast cancer, especially axillary lymphadenectomy (AL), can cause blood circulatory changes, also partial or total lesion of the sensory nerve intercostobrachial, often causing anesthesia or hypoesthesia in the corresponding dermatome ipsilateral upper limb surgery. Objective: to investigate the influence of high voltage electrical stimulation (HVES) in the in the blood flow and tactile sensitivity in nerve path intercostobrachial of women undergoing AL. Methodology: sample of 30 volunteers, aged between 40 and 60 years, divided into two equal groups (n = 15): women with axillary dissection for breast cancer undergoing therapeutic procedure (GAL) and control group (CG) composed of women who did not undergoing axillary surgery. The treatment procedure consist of the application of high voltage electrical simulation for 30 minutes in both limbs twice a week over the course of seven weeks. The profile of blood flow, including speed, direction were evaluated by means of continuous wave Doppler ultrasound. The assessment of tactile sensitivity was accomplished through esthesiometer in three stages: before the start of the first therapeutic procedure, after completion of the intervention and 30 days after the end of treatment (wash-out). The data will be analyzed using descriptive statistics (ANOVA) even as the hypothesis testing of Shapiro-Wilk and if the data are not normally distributed, non-parametric tests will be used. For the analyses will be used SPSS software with critical level of 5%. The results obtained on this study aim to justify therapies for intervention with that equipment in the treatment of morbidities caused by axillary linfadenectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Procedure: High voltage electrical stimulation - ( healthy women ), Device: Neurodyn High Volt Model (IBRAMED)Healthy women undergoing high voltage electrical stimulation |
| Axillary lymphadenectomy | Experimental | Procedure: high voltage electrical stimulation - axillary lymphadenectomy, Device: Neurodyn High Volt Model (IBRAMED)Axillary lymphadenectomy volunteers undergoing to high voltage electrical stimulation |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women, 40 to 60 years old, with abnormal sensitivity of the ipsilateral upper limb due to Type Madden Modified Radical Mastectomy for breast cancer with axillary lymphadenectomy
Key exclusion criteria (1 listed)
- patients undergoing other types of surgery that is not considered in the inclusion criteria, bilateral mastectomy, has a diagnosis of metastases, and skin disorders such as ulcers or erysipelas in the region (or nearby) the intercostal nerve pathway. We also excluded volunteers with some sort of cognitive impairment
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 |
|---|---|---|
| high voltage electrical stimulation - axillary lymphadenectomyWill be used high voltage electrical stimulation, Neurodyn High Volt Model (IBRAMED), twice a week, over the course of seven weeks,in 20-minute sessions on alternate days. The parameters are: high voltage pulsed current, monopolar (cathode), 100 Hz, synchronized mode, on/off relationship of 3:9 seconds, rise/decay 2:1 seconds, and motor threshold. The electrodes are positioned in the middle and distal thirds of the anterior surface of the forearm and arm. | Procedure or surgery | Axillary lymphadenectomy |
| High voltage electrical stimulation - ( healthy women )Will be used high voltage electrical stimulation, Neurodyn High Volt Model (IBRAMED), twice a week, over the course of seven weeks,in 20-minute sessions on alternate days. The parameters are: high voltage pulsed current, monopolar (cathode), 100 Hz, synchronized mode, on/off relationship of 3:9 seconds, rise/decay 2:1 seconds, and motor threshold. The electrodes are positioned in the middle and distal thirds of the anterior surface of the forearm and arm. | Procedure or surgery | Healthy |
| Neurodyn High Volt Model (IBRAMED) | Device | Axillary lymphadenectomy, Healthy |
Primary outcome
Tactile sensitivity
Time frame: 2 years
Will be used Estesiômetro Semmes-Weinstein (SORRY®) to evaluate the tactile sensibility in dermatomes corresponding on the medial and superior-posterior arm.
1 secondary outcome
Blood flow velocity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high voltage electrical stimulation - axillary lymphadenectomy, High voltage electrical stimulation - ( healthy women ) and Neurodyn High Volt Model (IBRAMED) in people with Breast Cancer, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 1 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 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 C Guirro, Ph.D (551636024584, ecguirro@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactile sensitivity (time frame: 2 years). 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 16 Jul 2013.