NCT01893957

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

11 months

First QC Date

June 21, 2013

Last Update Submit

July 15, 2013

Conditions

Breast Cancer

Keywords

breast cancerphysical therapyelectrical stimulationtactile sensitivityflow blood

Outcome Measures

Primary Outcomes (1)

  • Tactile sensitivity

    Will be used Estesiômetro Semmes-Weinstein (SORRY®) to evaluate the tactile sensibility in dermatomes corresponding on the medial and superior-posterior arm.

    2 years

Secondary Outcomes (1)

  • Blood flow velocity

    2 years

Study Arms (2)

Healthy

EXPERIMENTAL

Healthy women undergoing high voltage electrical stimulation

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

Procedure: high voltage electrical stimulation - axillary lymphadenectomyDevice: Neurodyn High Volt Model (IBRAMED)

Interventions

high voltage electrical stimulation - axillary lymphadenectomyPROCEDURE

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.

Axillary lymphadenectomy
High voltage electrical stimulation - ( healthy women )PROCEDURE

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.

Healthy
Neurodyn High Volt Model (IBRAMED)DEVICE
Axillary lymphadenectomyHealthy

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School of Ribeirão Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Elaine C Guirro, Ph.D

CONTACT

551636024584ecguirro@fmrp.usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Professor

Study Record Dates

First Submitted

June 21, 2013

First Posted

July 9, 2013

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations

BR(1)