Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Locally Advanced Head and Neck Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- EEG Spectrum Pre-Post tDCS Session
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Transcranial Direct Current Stimulation (tDCS) (Device)
Chemoradiotherapy Standard of Care
The control group will consist of patients receiving the Standard of care and no neuromodulation.
Outcomes
Primary Outcomes
EEG Spectrum Pre-Post tDCS Session
Time Frame: 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.
Visual Analog Scale (VAS)
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 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.
EEG Power Spectrum Week1/Week7
Time Frame: 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.
Secondary Outcomes
- Oral-Mucositis Weekly Evaluation - Overall(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(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(Pre-treatment (baseline), Week 7 of treatment, 1 week and 1 month follow-ups (post-treatment))
- Patient Weight(Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment))
- Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment(Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment))
Investigators
Alexandre DaSilva, DDS, DMedSc
Assistant Professor
University of Michigan