Peripheral NeuropathyCIPNNCT02107417
Study of TENS in Reducing Symptoms of Peripheral Neuropathy Induced by Chemotherapy
A study testing active TENS in people with Peripheral Neuropathy and Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral Neuropathy, Pain, Paresthesia
- What is being tested?
- active TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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%).
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Câncer de São Paulo
São Paulo, São Paulo
Raquel Ap Casarotto, PhD, 55-11-30917451, racasaro@usp.br
Tania Tonezzer, Post-GS, 55-11-971010062, ttonezzer@usp.br
About this study
Official title: 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).
Read the 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.
- 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%.
- Conditions
- Peripheral Neuropathy, Pain, Paresthesia, Neuritis
- Being tested
- active TENS, placebo TENS
- Keywords
- chemotherapy, pain, paresthesia, Physiotherapy, Transcutaneous Electrical Nerve Stimulation
- Medical subject headings
- Peripheral Nervous System Diseases, Pain, Paresthesia, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active TENSDevice
Also called Experimental Group (EG)- 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.
placebo TENSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) - TENS active | Experimental | 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. Receives: Device: active TENS |
| Control Group (CG)- Placebo TENS | Sham comparator | 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. Receives: Device: placebo TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
Secondary outcomes (4)
Evaluate the therapeutic response of TENS in symptoms of paresthesia
Measured: 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.
Measured: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
Evaluate the therapeutic response of TENS in symptoms of neuropathic pain.
Measured: 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.
Measured: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Tania Tonezzer, B.S, Principal investigator, Post-Graduation Student of Rehabilitation Science Program from Department of Speech Therapy, Physical Therapy and Occupational Therapy, São Paulo University, São Paulo, Brazil.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107417
- Sponsor's protocol ID
- USP-2014-NPIQ
- Acronym
- CIPN
- Status last verified
- Feb 2016
- First submitted
- 1 Apr 2014
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Transcutaneous Electrical Nerve Stimulation (Tens) in Reducing Symptoms of Peripheral Neuropathy Induced by Antineoplastic Chemotherapy
- ClinicalTrials.gov ID
- NCT02107417
- Acronym / sponsor ID
- CIPN / USP-2014-NPIQ
- Conditions
- Peripheral Neuropathy, Pain, Paresthesia, Neuritis
- Keywords
- chemotherapy, pain, paresthesia, Physiotherapy, Transcutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- 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
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) - TENS active | Experimental | Device: active TENSExperimental 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. |
| Control Group (CG)- Placebo TENS | Sham comparator | Device: placebo TENSControl 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- - 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active TENSAlso: Experimental Group (EG)- active TENSExperimental 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 | Experimental Group (EG) - TENS active |
| placebo TENSwho 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. | Device | Control Group (CG)- Placebo TENS |
Primary outcome
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).
4 secondary outcomes
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania Tonezzer, B.S principal investigator
Post-Graduation Student of Rehabilitation Science Program from Department of Speech Therapy, Physical Therapy and Occupational Therapy, São Paulo University, São Paulo, Brazil.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active TENS in people with Peripheral Neuropathy and Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raquel Ap Casarotto, PhD (55 1130917451, racasaro@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.