Ignite Creation Date:
2024-05-06 @ 2:43 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02107417
Status:
UNKNOWN
Last Update Posted:
2016-02-15
First Post:
2014-04-01
Brief Title:
Study of TENS in Reducing Symptoms of Peripheral Neuropathy Induced by Chemotherapy
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
The Use of Transcutaneous Electrical Nerve Stimulation Tens in Reducing Symptoms of Peripheral Neuropathy Induced by Antineoplastic Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIPN
Brief 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
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 patients 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 402 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
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 402 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None