Study of TENS in Reducing Symptoms of Peripheral Neuropathy Induced by Chemotherapy (CIPN)

February 12, 2016 updated by: University of Sao Paulo General Hospital

The Use of Transcutaneous Electrical Nerve Stimulation (Tens) in Reducing Symptoms of Peripheral Neuropathy Induced by Antineoplastic Chemotherapy

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chemotherapy-induced peripheral neuropathy (CIPN) results from damage or dysfunction of the peripheral nerves and is one of the most common side effects of antineoplastic chemotherapy when neurotoxic drugs are used. Pain and paresthesia symptoms are prevalent, causing chronic discomfort and loss of functional abilities whilst also interfering negatively with quality of life and the patient's autonomy. In a pilot study of patients with CIPN, there was evidence that Transcutaneous Electrical Nerve Stimulation (TENS) improved the painful symptoms of patients with CIPN. This study aims to investigate the effects of TENS in reducing the symptoms of pain and numbness and improve the daily lives of cancer patients who have CIPN.

1. Primary Objectives Evaluate the effects of TENS in the reduction of symptoms related to peripheral neuropathy due to chemotherapy treatment of a high and moderate neurotoxic potential in cancer patients.

Secondary Objectives:

  • Evaluate the therapeutic response of TENS with frequency variation (FV) in symptoms of paresthesia
  • Evaluate the therapeutic response of TENS with frequency variation (FV) in activities of the daily lives of patients
  • Evaluate the therapeutic response of TENS with frequency variation (FV) in symptoms of neuropathic pain.
  • Evaluate the factors associated with better treatment response in paresthesia, in pain and activities of daily living.

Eligibility criteria: The participants of the research will include patients with any cancer diagnosis who are being subjected to chemotherapy in either adjuvant or neoadjuvant therapy, containing in its protocol at least one chemotherapeutic drug of moderate and high neurotoxic potential.

The participants of the research 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. The treatment will be given on the same day as the chemotherapy, and will be given from home within 3 cycles. The participants will be divided into 2 groups: Experimental Group (EG) who will be administering the active TENS and the Control Group (CG) who will be administering the placebo TENS. The evaluation of the effects will be measured through the following instruments: Classification of neuropathy by the CTCAE (Common Terminology Criteria for Adverse Events) version 4.02 2009, scale of functionality ECOG, the Questionnaire of Neurotoxicity Induced by Antineoplastics (QNIA) for the evaluation of the symptoms of CIPN, and the Analogue Visual Scale (AVS) to assess the symptoms of pain and paresthesia. The error α is estimated at 5%.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Instituto do Câncer de São Paulo
        • Contact:
          • Raquel Ap Casarotto, PhD
          • Phone Number: 55-11-30917451
          • Email: racasaro@usp.br
        • Contact:
        • Principal Investigator:
          • Raquel Ap Casarotto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - Patients who are being subjected to chemotherapeutic treatment with drugs or association of drugs with high and moderate neurotoxic degree and who present neuropathic pain and / or peripheral sensory neuropathy grade I and II of the CTCAE scale (Appendix A).
  • Patients showing symptoms of peripheral neuropathy in the first cycle of chemotherapeutic treatment with three points on the visual analogue scale of pain and paresthesia.
  • Patients aged between 18 and 70 years.
  • Patients without Diabetes Mellitus before and during chemotherapy treatment.
  • Patients who have not undergone previous chemotherapy regimens with neurotoxic drugs.
  • Patients with ECOG performance status ≤ 2 (Karnofsky ≥ 50%).
  • Patients that do not have a cardiac pacemaker.
  • Patients without changes in sensitivity prior to chemotherapy.
  • Patients without skin lesions at the site or around the site of application of the electrodes.
  • Patients without cognitive and comprehension difficulties.
  • Agree to participate in the study by signing the Free and Clarified Term of Consent- FCTC

Exclusion Criteria:

  • Patients who have already undergone chemotherapy previously with drugs or have had association with neurotoxic drugs which have presented neuropathic pain and/or sensory peripheral neuropathy.
  • Patients who have previously had acupuncture for the treatment of neuropathic pain and/or sensory peripheral neuropathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (EG) - TENS active
Experimental Group (EG) - TENS active: who will receive the application of active TENS. The participants of these group will receive TENS active 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: 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.
Other Names:
  • Experimental Group (EG)- active TENS
Sham Comparator: Control Group (CG)- Placebo TENS
Control Group (CG) 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, . It has an application time of 60 minutes The TENS-placebo will be applied where no current will be emitted.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the effects of TENS in the reduction of symptoms related to peripheral neuropathy due to chemotherapy treatment of a high and moderate neurotoxic potential in cancer patients.
Time Frame: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the therapeutic response of TENS in symptoms of paresthesia
Time Frame: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
Evaluate the therapeutic response of TENS in activities of the daily lives of patients.
Time Frame: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
Evaluate the therapeutic response of TENS in symptoms of neuropathic pain.
Time Frame: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
Evaluate the factors associated with better treatment response in paresthesia, in pain and activities of daily living.
Time Frame: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Instituto do Cancer do Estado de São Paulo
Instituto Nacional de Cancer, Brazil
Hospital de Câncer de Barretos
Centro de Estudos e Pesquisas Oncológicas (CEPO)
Centro de Oncologia do Hospital Universitário São Francisco

Investigators

  • Principal Investigator: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

February 15, 2016

Last Update Submitted That Met QC Criteria

February 12, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP-2014-NPIQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on active TENS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe