Study of TENS in Reducing Symptoms of Peripheral Neuropathy Induced by Chemotherapy

NCT02107417 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-02-15

No results posted yet for this study

Summary

This study aims to investigate the effects of Transcutaneous Electrical Nerve Stimulation (TENS) in reducing the symptoms of pain and numbness and improve the daily lives of cancer patients who have Chemotherapy-induced peripheral neuropathy (CIPN).

Conditions

Interventions

DEVICE

active TENS

Experimental Group (EG) who will receive the application of active TENS. The participants of these group will receive TENS within the following parameters: VF mode TENS with a variable frequency between 7 Hz and 65 Hz. It has a pulse width of 200 µs, this is the highest tolerable intensity while still remaining comfortable for the patient. It has an application time of 60 minutes with the highest tolerable intensity, while still remaining comfortable for the patient.

DEVICE

placebo TENS

who will be administering the placebo TENS.The participants of these group will receive TENS within the following parameters: VF mode TENS with a variable frequency between 7 Hz and 65 Hz. It has a pulse width of 200 µs, this is the highest tolerable intensity while still remaining comfortable for the patient. It has an application time of 60 minutes The TENS-placebo will be applied where no current will be emitted. Patients in the placebo group will only feel the tingling for 45 seconds and after this period the device will not emit impulses, but it will work for 1 hour.

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    collaborator OTHER_GOV
  • Instituto do Cancer do Estado de São Paulo

    collaborator OTHER
  • Hospital de Câncer de Barretos

    collaborator OTHER
  • Centro de Estudos e Pesquisas Oncológicas (CEPO)

    collaborator UNKNOWN
  • Centro de Oncologia do Hospital Universitário São Francisco

    collaborator UNKNOWN
  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Tania Tonezzer, B.S · Post-Graduation Student of Rehabilitation Science Program from Department of Speech Therapy, Physical Therapy and Occupational Therapy, São Paulo University, São Paulo, Brazil.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-12-31
Completion
2017-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02107417 on ClinicalTrials.gov