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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University of Sao Paulo General Hospital
Sponsor:
Collaborators:
Instituto Nacional de Cancer, Brazil
Instituto do Cancer do Estado de São Paulo
Hospital de Câncer de Barretos
Centro de Estudos e Pesquisas Oncológicas (CEPO)
Centro de Oncologia do Hospital Universitário São Francisco
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02107417
First received: April 1, 2014
Last updated: April 7, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention
Peripheral Neuropathy
Pain
Paresthesia
Neuritis
Device: active TENS
Device: placebo TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Use of Transcutaneous Electrical Nerve Stimulation (Tens) in Reducing Symptoms of Peripheral Neuropathy Induced by Antineoplastic Chemotherapy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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%.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02107417

Contacts
Contact: Raquel Ap Casarotto, PhD 55 1130917451 racasaro@usp.br
Contact: Tania Tonezzer, Post-GS 55 11 971010062 ttonezzer@uol.com.br

Locations
Brazil
Instituto do Câncer de São Paulo Not yet recruiting
São Paulo, Brazil
Contact: Raquel Ap Casarotto, PhD    55-11-30917451    racasaro@usp.br   
Contact: Tania Tonezzer, Post-GS    55-11-971010062    ttonezzer@usp.br   
Principal Investigator: Raquel Ap Casarotto         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Instituto Nacional de Cancer, Brazil
Instituto do Cancer do Estado de São Paulo
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.
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02107417     History of Changes
Other Study ID Numbers: USP-2014-NPIQ
Study First Received: April 1, 2014
Last Updated: April 7, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
chemotherapy
pain
paresthesia
Physiotherapy
Transcutaneous Electrical Nerve Stimulation

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Paresthesia
Neuromuscular Diseases
Nervous System Diseases
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014