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

Peripheral Neuropathy research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Peripheral Neuropathy

Pain

Paresthesia

Neuritis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device: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: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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Experimental Group (EG) - TENS activeExperimental 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 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.

Study Status

Recruiting

Start Date: June 2014

Completed Date: December 2017

Phase: N/A

Type: Interventional

Design:

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.

Secondary Outcome: Evaluate the therapeutic response of TENS in symptoms of paresthesia

Study sponsors, principal investigator, and references

Principal Investigator: Tania Tonezzer, B.S

Lead Sponsor: University of Sao Paulo General Hospital

Collaborator: Instituto Nacional de Cancer, Brazil

More information:https://clinicaltrials.gov/show/NCT02107417

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