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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Head and Neck
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation (tDCS)

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).

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	A Visual Analog Scale (VAS) will be used to assess patient-reported odynophagia at weekly Radiation Oncology on-treatment visits (OTVs). The VAS is a traditional pain assessment tool that has been used and validated widely in both clinical and research settings, including studies of oral mucositis pain. This scale ranges from 0-100, in which 0 means no odynophagia, and 100 means highest level of odynophagia ever.	Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
EEG Power Spectrum Week1/Week7	EEG data power spectrum analysis. Week1 and Week 7 difference. Note: the control participant's data was not reported due to limited number of participant in the control group. The report was divided into five frequency bands: Delta = 0-4 Hz; Theta = 4-7 Hz; Alpha = 8-15 Hz; Beta= 16-31 Hz; Gamma 32-50 Hz The data was recorded at P3, Fz, Cz, F3, Fp1, Fp2 points in the international 10-20 system. The analysis was done using EEGLab V 14.1.1.	Week1/Week7
EEG Spectrum Pre-Post tDCS Session	EEG data power spectrum analysis. Pre/Post-tDCS session. The report was divided into five frequency bands: Delta = 0-4 Hz; Theta = 4-7 Hz; Alpha = 8-15 Hz; Beta= 16-31 Hz; Gamma 32-50 Hz The data was recorded at P3, Fz, Cz, F3, Fp1, Fp2 points in the international 10-20 system. Note: the control participant's data was not reported due to limited number of participant in the control group.	Pre/Post-tDCS Session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral-Mucositis Weekly Evaluation - Overall	1-7 scale grading self-evaluated overall physical condition, 7= Excellent, 1 = Very poor.	Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
Patient Weight	Participant's weight each measurement time point. Note: 0 means data missing.	Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
Positive and Negative Affect Schedule	The General Positive and General Negative scores in the PANAS forms are reported for both pre- and post- treatment. The General Positive (GP) and General Negative (GN) scores were reported. Each score ranges from 10-50, in which 10 = lowest (positive/negative emotional level) and 50 = highest (positive/negative emotional level).	Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
Washington Quality Of Life Questionnaire	The Washington Quality Of Life questionnaire (QOL) is one of the most frequently reported health-related QOL questionnaires in head and neck cancer. This questionnaire scaled from 0 (worst) to 100 (best) according to the hierarchy of response.	Pre-treatment (baseline), Week 7 of treatment, 1 week and 1 month follow-ups (post-treatment)
Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment	The Present Pain Intensity (PPI) index is recorded as a number ranges from 0 to 5, in which each number is associated with the following words: 0 no pain, 1 mild, 2 discomforting, 3 distressing, 4 horrible, 5 excruciating.	Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Alexandre DaSilva, DDS, DMedSc, University of Michigan

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: tDCS; EEG; fNIRS; Cancer Pain
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: HUM 78942; U036889 (Other Identifier: UMichigan)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes