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Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT02366611
Recruitment Status : Recruiting
First Posted : February 19, 2015
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Alexandre DaSilva, DDS, MS, University of Michigan

Brief Summary:
The purpose of this study is to determine if Transcranial Direct Current Stimulation (tDCS) can reduce pain perception associated with the effects of receiving definitive radiation therapy or chemoradiotherapy in head and neck cancer (HNCa) patients.

Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Device: Transcranial Direct Current Stimulation (tDCS) Not Applicable

Detailed Description:

The goal of this study is to investigate the effectiveness of tDCS as a novel pain relief modality for odynophagia due to mucositis in patients with locally advanced head and neck cancer undergoing definitive radiation therapy or chemoradiotherapy. Participants will be randomized into one of two arms: (1) Treatment: radiation/chemoradiotherapy standard of care + tDCS neuromodulation or (2) Control: radiation/chemoradiotherapy standard of care only.

Patients in the treatment arm will undergo tDCS stimulation on the day of their radiation/chemoradiotherapy appointments, prior to receiving treatment when doing tDCS session in clinic or after to receiving treatment when doing tDCS session at home. This will occur daily (5 days per week) during the second and third weeks of therapy, three times per week during the fourth and fifth weeks, and twice per week during the sixth and seventh weeks.

Patients will also have EEG and fNIRS recordings during the study. This will occur at the pre-study visit, the first stimulation appointment, the third week, the 7th week, and during the follow-up appointments (one-week and one-month).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Locally Advanced Head and Neck Cancer
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcranial Direct Current Stimulation (tDCS)
tDCS is a method of non-invasive brain stimulation that is based on the application of a weak direct current to the head that flows between two relatively large electrodes—anode and cathode. tDCS offers a unique analgesic modality of central pain neuromodulation by altering the activity of key sensory and motor cortical structures. Participants in this arm will undergo 20 tDCS sessions, tDCS in clinic and remotely supervised tDCS, and 2mA of transcranial direct current stimulation will be applied for 20 minutes.
Device: Transcranial Direct Current Stimulation (tDCS)
tDCS is a non-invasive brain neuromodulatory method that involves sending a weak electrical current to the brain. 2mA of tDCS will be applied for 20 minutes at each session and participants will undergo a total of 20 sessions over a 7-week period.

No Intervention: Chemoradiotherapy Standard of Care
The control group will consist of patients receiving the Standard of care and no neuromodulation.



Primary Outcome Measures :
  1. Change from Baseline in Visual Analog Scale [ Time Frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment) ]
    A Visual Analog Scale (VAS) will be used to assess change in patient-reported odynophagia.


Secondary Outcome Measures :
  1. Change from Baseline in WHO Scale [ Time Frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment) ]
    0-4 scale grading Oral Mucositis, including both visual and functional assessments



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with AJCC stage III-IV head and neck malignancy scheduled for definitive radiation therapy or chemoradiotherapy, and who are capable of understanding and adhering to the protocol requirements.

Exclusion Criteria:

  • Substantial dementia
  • Patients are actively being treated for another cancer at the time of enrollment.
  • Any condition that would prevent use of tDCS including skull abnormality, implanted metal, implanted electronic device, seizure disorder, neurologic condition.
  • Use of an investigational drug or device within 30 days of study screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366611


Contacts
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Contact: Elizabeth Hatfield, DDS lizhat@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Alexandre F DaSilva, DDS. DMedS    734-615-9390    contactHOPE@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Alexandre DaSilva, DDS, DMedSc University of Michigan

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Responsible Party: Alexandre DaSilva, DDS, MS, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02366611     History of Changes
Other Study ID Numbers: HUM 78942
U036889 ( Other Identifier: UMichigan )
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Alexandre DaSilva, DDS, MS, University of Michigan:
Cancer Pain
EEG
fNIRS
tDCS

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms