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Completed

NCT Number: NCT02366611

Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for 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.

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Key information

Conditions

Cancer of Head and Neck Cancer Pain Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48106, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Oral-Mucositis Weekly Evaluation - Overall

    Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)

    1-7 scale grading self-evaluated overall physical condition, 7= Excellent, 1 = Very poor.

  2. Patient Weight

    Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)

    Participant's weight each measurement time point. Note: 0 means data missing.

  3. Positive and Negative Affect Schedule

    Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)

    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).

  4. Washington Quality Of Life Questionnaire

    Time frame: Pre-treatment (baseline), Week 7 of treatment, 1 week and 1 month follow-ups (post-treatment)

    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.

  5. Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment

    Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2015
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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