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
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Head and Neck||Device: Transcranial Direct Current Stimulation (tDCS)||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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.
- 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.
- 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
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
|Contact: Elizabeth Hatfield, DDSfirstname.lastname@example.org|
|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|
|Principal Investigator:||Alexandre DaSilva, DDS, DMedSc||University of Michigan|