NCT02107417

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

April 1, 2014

Last Update Submit

February 12, 2016

Conditions

Peripheral NeuropathyPainParesthesiaNeuritis

Keywords

chemotherapypainparesthesiaPhysiotherapyTranscutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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.

    At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).

  • Evaluate the therapeutic response of TENS in symptoms of neuropathic pain.

    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.

    At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).

Study Arms (2)

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.

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.

Device: placebo TENS

Interventions

active TENSDEVICE

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.

Also known as: Experimental Group (EG)- active TENS
Experimental Group (EG) - TENS active
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.

Control Group (CG)- Placebo TENS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Câncer de São Paulo

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System DiseasesPainParesthesiaNeuritis

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation Disorders

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Ap Casarotto, PhD

CONTACT

55 1130917451racasaro@usp.br

Tania Tonezzer, Post-GS

CONTACT

55 11 971010062ttonezzer@uol.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 8, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2017

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations

BR(1)