Clinical trial NCT02366611: Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer
Official title: Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head and Neck
Keywords: Cancer Pain
EEG
fNIRS
tDCS
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
measure: EEG Power Spectrum Week1/Week7
timeFrame: Week1/Week7
measure: EEG Spectrum Pre-Post tDCS Session
timeFrame: Pre/Post-tDCS Session
Secondary outcomes:
measure: Oral-Mucositis Weekly Evaluation - Overall
timeFrame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
measure: Patient Weight
timeFrame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
measure: Positive and Negative Affect Schedule
timeFrame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
measure: Washington Quality Of Life Questionnaire
timeFrame: Pre-treatment (baseline), Week 7 of treatment, 1 week and 1 month follow-ups (post-treatment)
measure: Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
timeFrame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alexandre DaSilva, DDS, DMedSc
role: PRINCIPAL_INVESTIGATOR
References: