Cancer of Head and Neck
Conditions
Keywords
Cancer Pain, EEG, fNIRS, tDCS
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).
Interventions
DEVICETranscranial 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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 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 | 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. |
| EEG Spectrum Pre-Post tDCS Session | 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
| Measure | Time frame | Description |
|---|---|---|
| Washington Quality Of Life Questionnaire | 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. |
| 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) | 1-7 scale grading self-evaluated overall physical condition, 7= Excellent, 1 = Very poor. |
| 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) | 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. |
| Patient Weight | 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. |
| 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) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 10 |
| Chemoradiotherapy Standard of Care The control group will consist of patients receiving the Standard of care and no neuromodulation. | 1 |
| Total | 11 |
Baseline characteristics
| Characteristic | Transcranial Direct Current Stimulation (tDCS) | Chemoradiotherapy Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 8.1 | 58 years | 60.1 years STANDARD_DEVIATION 7.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 1 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 1 |
| other Total, other adverse events | 0 / 10 | 0 / 1 |
| serious Total, serious adverse events | 0 / 10 | 0 / 1 |
Outcome results
Primary
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.
Time frame: Week1/Week7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week1_F3 | 118.6 Power(10*log10(muV))^2 | Standard Deviation 3.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week7_Fz | 146.7 Power(10*log10(muV))^2 | Standard Deviation 2.9 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week1_F3 | 114.1 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week7_Fz | 141.9 Power(10*log10(muV))^2 | Standard Deviation 1.6 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week1_F3 | 113.1 Power(10*log10(muV))^2 | Standard Deviation 1.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week1_P3 | 115.3 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week1_F3 | 110.7 Power(10*log10(muV))^2 | Standard Deviation 0.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week7_Fz | 137.1 Power(10*log10(muV))^2 | Standard Deviation 1.7 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week1_F3 | 111.1 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week7_P3 | 129.5 Power(10*log10(muV))^2 | Standard Deviation 3.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week7_F3 | 140.3 Power(10*log10(muV))^2 | Standard Deviation 3.7 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week7_Fz | 129.3 Power(10*log10(muV))^2 | Standard Deviation 2.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week7_F3 | 133.9 Power(10*log10(muV))^2 | Standard Deviation 1.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week7_P3 | 107.4 Power(10*log10(muV))^2 | Standard Deviation 1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week7_F3 | 127.7 Power(10*log10(muV))^2 | Standard Deviation 2.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week7_Fz | 124.0 Power(10*log10(muV))^2 | Standard Deviation 1.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week7_F3 | 121.3 Power(10*log10(muV))^2 | Standard Deviation 2.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week1_P3 | 114.2 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week7_F3 | 116.1 Power(10*log10(muV))^2 | Standard Deviation 1.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week1_Cz | 117.9 Power(10*log10(muV))^2 | Standard Deviation 2.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week1_Fp1 | 119.0 Power(10*log10(muV))^2 | Standard Deviation 4.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week1_Fz | 118.6 Power(10*log10(muV))^2 | Standard Deviation 2.8 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week1_Fp1 | 113.0 Power(10*log10(muV))^2 | Standard Deviation 0.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week1_Cz | 114.3 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week1_Fp1 | 110.9 Power(10*log10(muV))^2 | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week7_P3 | 123.5 Power(10*log10(muV))^2 | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week1_Fp1 | 109.0 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week1_Cz | 113.3 Power(10*log10(muV))^2 | Standard Deviation 1.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week1_Fp1 | 109.0 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week1_Fz | 114.7 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week7_Fp1 | 132.3 Power(10*log10(muV))^2 | Standard Deviation 2.9 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week1_Cz | 110.7 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week7_Fp1 | 127.3 Power(10*log10(muV))^2 | Standard Deviation 1.6 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week1_P3 | 115.4 Power(10*log10(muV))^2 | Standard Deviation 0.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week7_Fp1 | 122.6 Power(10*log10(muV))^2 | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week1_Cz | 111.4 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week7_Fp1 | 114.5 Power(10*log10(muV))^2 | Standard Deviation 2.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week1_Fz | 113.3 Power(10*log10(muV))^2 | Standard Deviation 1.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week7_Fp1 | 109.3 Power(10*log10(muV))^2 | Standard Deviation 1.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week7_Cz | 141.7 Power(10*log10(muV))^2 | Standard Deviation 3.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week1_Fp2 | 120.4 Power(10*log10(muV))^2 | Standard Deviation 3.8 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week7_P3 | 118.3 Power(10*log10(muV))^2 | Standard Deviation 1.8 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week1_Fp2 | 115.0 Power(10*log10(muV))^2 | Standard Deviation 0.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week7_Cz | 136.5 Power(10*log10(muV))^2 | Standard Deviation 1.6 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week1_Fp2 | 112.4 Power(10*log10(muV))^2 | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week1_Fz | 110.8 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week1_Fp2 | 108.8 Power(10*log10(muV))^2 | Standard Deviation 0.7 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week7_Cz | 132.3 Power(10*log10(muV))^2 | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week1_Fp2 | 108.7 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week1_P3 | 115 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week7_Fp2 | 129.1 Power(10*log10(muV))^2 | Standard Deviation 3.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week7_Cz | 123.8 Power(10*log10(muV))^2 | Standard Deviation 2.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Theta_Week7_Fp2 | 123.0 Power(10*log10(muV))^2 | Standard Deviation 1.6 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week1_Fz | 111.7 Power(10*log10(muV))^2 | Standard Deviation 0.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Alpha_Week7_Fp2 | 119.0 Power(10*log10(muV))^2 | Standard Deviation 1.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week7_Cz | 118.3 Power(10*log10(muV))^2 | Standard Deviation 1.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week7_Fp2 | 111.4 Power(10*log10(muV))^2 | Standard Deviation 2.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Beta_Week7_P3 | 112.0 Power(10*log10(muV))^2 | Standard Deviation 2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Gamma_Week7_Fp2 | 106.6 Power(10*log10(muV))^2 | Standard Deviation 1.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Power Spectrum Week1/Week7 | Delta_Week1_P3 | 118.9 Power(10*log10(muV))^2 | Standard Deviation 2.4 |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week7_Fp2 | 56.9 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week1_P3 | 111 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week1_P3 | 86.9 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week1_P3 | 74 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week1_P3 | 61.6 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week1_P3 | 50.1 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week7_P3 | 127.6 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week7_P3 | 91.7 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week7_P3 | 78.9 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week7_Fz | 127.1 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week7_P3 | 66.9 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week7_P3 | 55.4 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week1_Fz | 126.4 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week1_Fz | 90.5 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week1_Fz | 77.5 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week1_Fz | 64.5 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week1_Fz | 51.3 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week7_Fz | 91.2 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week7_Fz | 78.6 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week7_Fz | 68.1 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week7_Fz | 57.6 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week1_Cz | 125.5 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week1_Cz | 89.6 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week1_Cz | 76.5 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week1_Cz | 63.7 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week1_Cz | 51 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week7_Cz | 126.5 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week7_Cz | 90.6 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week7_Cz | 77.9 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week7_Cz | 67.1 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week7_Cz | 56.4 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week1_F3 | 125.9 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week1_F3 | 90 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week1_F3 | 77 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week1_F3 | 64 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week1_F3 | 49.8 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week7_F3 | 129.5 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week7_F3 | 94.1 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week7_F3 | 81.1 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week7_F3 | 69.4 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week7_F3 | 57.2 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week1_Fp1 | 130 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week1_Fp1 | 94.1 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week1_Fp1 | 81.1 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week1_Fp1 | 68.3 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week1_Fp1 | 53.1 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week7_Fp1 | 129.5 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week7_Fp1 | 93.2 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week7_Fp1 | 80.3 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week7_Fp1 | 68.3 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week7_Fp1 | 56 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week1_Fp2 | 128.8 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week1_Fp2 | 92.9 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week1_Fp2 | 80 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week1_Fp2 | 67.2 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Gamma_Week1_Fp2 | 52.6 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Delta_Week7_Fp2 | 127.6 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Theta_Week7_Fp2 | 91.7 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Alpha_Week7_Fp2 | 79 Power(10*log10(muV))^2 | — |
| Chemoradiotherapy Standard of Care | EEG Power Spectrum Week1/Week7 | Beta_Week7_Fp2 | 67.9 Power(10*log10(muV))^2 | — |
Primary
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.
Time frame: Pre/Post-tDCS Session
Population: Because this piece of result compared EEG data pre- and post- tDCS stimulation, however the control (regular CRT) arm was not stimulated, thus the data were not collected and presented below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Pre_P3 | 114.8 Power(10*log10(muV))^2 | Standard Deviation 2.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Pre_P3 | 111.0 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Pre_P3 | 109.8 Power(10*log10(muV))^2 | Standard Deviation 1.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Pre_P3 | 105.9 Power(10*log10(muV))^2 | Standard Deviation 1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Pre_P3 | 104.5 Power(10*log10(muV))^2 | Standard Deviation 0.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Post_P3 | 115.6 Power(10*log10(muV))^2 | Standard Deviation 2.6 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Post_P3 | 112.2 Power(10*log10(muV))^2 | Standard Deviation 0.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Post_P3 | 111.9 Power(10*log10(muV))^2 | Standard Deviation 1.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Post_P3 | 109 Power(10*log10(muV))^2 | Standard Deviation 0.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Post_P3 | 108.8 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Pre_Fz | 115.4 Power(10*log10(muV))^2 | Standard Deviation 2.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Pre_Fz | 111.4 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Pre_Fz | 109.1 Power(10*log10(muV))^2 | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Pre_Fz | 104.7 Power(10*log10(muV))^2 | Standard Deviation 1.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Pre_Fz | 103.1 Power(10*log10(muV))^2 | Standard Deviation 0.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Post_Fz | 115.3 Power(10*log10(muV))^2 | Standard Deviation 2.6 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Post_Fz | 111.7 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Post_Fz | 110 Power(10*log10(muV))^2 | Standard Deviation 1.6 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Post_Fz | 106.7 Power(10*log10(muV))^2 | Standard Deviation 0.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Post_Fz | 106.3 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Pre_Cz | 115.9 Power(10*log10(muV))^2 | Standard Deviation 2.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Pre_Cz | 112.1 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Pre_Cz | 110 Power(10*log10(muV))^2 | Standard Deviation 1.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Pre_Cz | 105.8 Power(10*log10(muV))^2 | Standard Deviation 1.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Pre_Cz | 103.9 Power(10*log10(muV))^2 | Standard Deviation 0.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Post_Cz | 116.4 Power(10*log10(muV))^2 | Standard Deviation 2.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Post_Cz | 112.9 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Post_Cz | 111.3 Power(10*log10(muV))^2 | Standard Deviation 1.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Post_Cz | 107.4 Power(10*log10(muV))^2 | Standard Deviation 0.8 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Post_Cz | 106.5 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Pre_F3 | 115.7 Power(10*log10(muV))^2 | Standard Deviation 2.8 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Pre_F3 | 111.4 Power(10*log10(muV))^2 | Standard Deviation 0.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Pre_F3 | 109.3 Power(10*log10(muV))^2 | Standard Deviation 1.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Pre_F3 | 105.6 Power(10*log10(muV))^2 | Standard Deviation 0.8 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Pre_F3 | 104.3 Power(10*log10(muV))^2 | Standard Deviation 0.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Post_F3 | 115.9 Power(10*log10(muV))^2 | Standard Deviation 2.8 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Post_F3 | 112 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Post_F3 | 110.4 Power(10*log10(muV))^2 | Standard Deviation 1.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Post_F3 | 107.8 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Post_F3 | 107.6 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Pre_Fp1 | 115.5 Power(10*log10(muV))^2 | Standard Deviation 3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Pre_Fp1 | 110.8 Power(10*log10(muV))^2 | Standard Deviation 0.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Pre_Fp1 | 108.4 Power(10*log10(muV))^2 | Standard Deviation 1.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Pre_Fp1 | 104.6 Power(10*log10(muV))^2 | Standard Deviation 0.9 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Pre_Fp1 | 103 Power(10*log10(muV))^2 | Standard Deviation 0.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Post_Fp1 | 114.8 Power(10*log10(muV))^2 | Standard Deviation 2.8 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Post_Fp1 | 110.9 Power(10*log10(muV))^2 | Standard Deviation 0.3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Post_Fp1 | 109.0 Power(10*log10(muV))^2 | Standard Deviation 1.6 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Post_Fp1 | 105.7 Power(10*log10(muV))^2 | Standard Deviation 0.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Post_Fp1 | 105.1 Power(10*log10(muV))^2 | Standard Deviation 0.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Pre_Fp2 | 114.9 Power(10*log10(muV))^2 | Standard Deviation 2.7 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Pre_Fp2 | 110.4 Power(10*log10(muV))^2 | Standard Deviation 0.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Pre_Fp2 | 108 Power(10*log10(muV))^2 | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Pre_Fp2 | 104 Power(10*log10(muV))^2 | Standard Deviation 0.9 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Pre_Fp2 | 102.4 Power(10*log10(muV))^2 | Standard Deviation 0.1 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Delta_Post_Fp2 | 114.8 Power(10*log10(muV))^2 | Standard Deviation 3 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Theta_Post_Fp2 | 110.7 Power(10*log10(muV))^2 | Standard Deviation 0.2 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Alpha_Post_Fp2 | 108.9 Power(10*log10(muV))^2 | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Beta_Post_Fp2 | 105.9 Power(10*log10(muV))^2 | Standard Deviation 0.4 |
| Transcranial Direct Current Stimulation (tDCS) | EEG Spectrum Pre-Post tDCS Session | Gamma_Post_Fp2 | 105.2 Power(10*log10(muV))^2 | Standard Deviation 0.1 |
Primary
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.
Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Visual Analog Scale (VAS) | Week2 | 11 score on a scale | Standard Deviation 14 |
| Transcranial Direct Current Stimulation (tDCS) | Visual Analog Scale (VAS) | Week5 | 32 score on a scale | Standard Deviation 28 |
| Transcranial Direct Current Stimulation (tDCS) | Visual Analog Scale (VAS) | Week1 | 11 score on a scale | Standard Deviation 14 |
| Transcranial Direct Current Stimulation (tDCS) | Visual Analog Scale (VAS) | Week6 | 40 score on a scale | Standard Deviation 19 |
| Transcranial Direct Current Stimulation (tDCS) | Visual Analog Scale (VAS) | Week3 | 25 score on a scale | Standard Deviation 19 |
| Transcranial Direct Current Stimulation (tDCS) | Visual Analog Scale (VAS) | Pre Study | 16 score on a scale | Standard Deviation 22 |
| Transcranial Direct Current Stimulation (tDCS) | Visual Analog Scale (VAS) | Follow Up Week 1 | 29 score on a scale | Standard Deviation 19 |
| Transcranial Direct Current Stimulation (tDCS) | Visual Analog Scale (VAS) | Week4 | 34 score on a scale | Standard Deviation 31 |
| Transcranial Direct Current Stimulation (tDCS) | Visual Analog Scale (VAS) | Follow Up Month 1 | 31 score on a scale | Standard Deviation 15 |
| Transcranial Direct Current Stimulation (tDCS) | Visual Analog Scale (VAS) | Week7 | 36 score on a scale | Standard Deviation 18 |
| Chemoradiotherapy Standard of Care | Visual Analog Scale (VAS) | Follow Up Month 1 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Visual Analog Scale (VAS) | Pre Study | 2 score on a scale | — |
| Chemoradiotherapy Standard of Care | Visual Analog Scale (VAS) | Week1 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Visual Analog Scale (VAS) | Week2 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Visual Analog Scale (VAS) | Week3 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Visual Analog Scale (VAS) | Week4 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Visual Analog Scale (VAS) | Week5 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Visual Analog Scale (VAS) | Week6 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Visual Analog Scale (VAS) | Week7 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Visual Analog Scale (VAS) | Follow Up Week 1 | 0 score on a scale | — |
Secondary
Oral-Mucositis Weekly Evaluation - Overall
1-7 scale grading self-evaluated overall physical condition, 7= Excellent, 1 = Very poor.
Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Oral-Mucositis Weekly Evaluation - Overall | Pre-Study | 4.9 score on a scale | Standard Deviation 1.1 |
| Transcranial Direct Current Stimulation (tDCS) | Oral-Mucositis Weekly Evaluation - Overall | Week1 | 5 score on a scale | Standard Deviation 1 |
| Transcranial Direct Current Stimulation (tDCS) | Oral-Mucositis Weekly Evaluation - Overall | Week2 | 4.8 score on a scale | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation (tDCS) | Oral-Mucositis Weekly Evaluation - Overall | Week3 | 4.6 score on a scale | Standard Deviation 1.2 |
| Transcranial Direct Current Stimulation (tDCS) | Oral-Mucositis Weekly Evaluation - Overall | Week4 | 4.9 score on a scale | Standard Deviation 0.6 |
| Transcranial Direct Current Stimulation (tDCS) | Oral-Mucositis Weekly Evaluation - Overall | Week5 | 4.7 score on a scale | Standard Deviation 0.7 |
| Transcranial Direct Current Stimulation (tDCS) | Oral-Mucositis Weekly Evaluation - Overall | Week6 | 4.7 score on a scale | Standard Deviation 0.7 |
| Transcranial Direct Current Stimulation (tDCS) | Oral-Mucositis Weekly Evaluation - Overall | Week7 | 4.9 score on a scale | Standard Deviation 0.8 |
| Transcranial Direct Current Stimulation (tDCS) | Oral-Mucositis Weekly Evaluation - Overall | FollowUp-Week1 | 4.5 score on a scale | Standard Deviation 1 |
| Transcranial Direct Current Stimulation (tDCS) | Oral-Mucositis Weekly Evaluation - Overall | FollowUp-Month1 | 4.6 score on a scale | Standard Deviation 0.9 |
| Chemoradiotherapy Standard of Care | Oral-Mucositis Weekly Evaluation - Overall | Week7 | 7 score on a scale | — |
| Chemoradiotherapy Standard of Care | Oral-Mucositis Weekly Evaluation - Overall | Pre-Study | 7 score on a scale | — |
| Chemoradiotherapy Standard of Care | Oral-Mucositis Weekly Evaluation - Overall | Week5 | 7 score on a scale | — |
| Chemoradiotherapy Standard of Care | Oral-Mucositis Weekly Evaluation - Overall | Week1 | 7 score on a scale | — |
| Chemoradiotherapy Standard of Care | Oral-Mucositis Weekly Evaluation - Overall | FollowUp-Month1 | 7 score on a scale | — |
| Chemoradiotherapy Standard of Care | Oral-Mucositis Weekly Evaluation - Overall | Week2 | 7 score on a scale | — |
| Chemoradiotherapy Standard of Care | Oral-Mucositis Weekly Evaluation - Overall | Week6 | 7 score on a scale | — |
| Chemoradiotherapy Standard of Care | Oral-Mucositis Weekly Evaluation - Overall | Week3 | 7 score on a scale | — |
| Chemoradiotherapy Standard of Care | Oral-Mucositis Weekly Evaluation - Overall | FollowUp-Week1 | 7 score on a scale | — |
| Chemoradiotherapy Standard of Care | Oral-Mucositis Weekly Evaluation - Overall | Week4 | 7 score on a scale | — |
Secondary
Patient Weight
Participant's weight each measurement time point. Note: 0 means data missing.
Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Patient Weight | Pre-Study | 229.2 pound | Standard Deviation 40.6 |
| Transcranial Direct Current Stimulation (tDCS) | Patient Weight | Week1 | 224.2 pound | Standard Deviation 42 |
| Transcranial Direct Current Stimulation (tDCS) | Patient Weight | Week2 | 246.2 pound | Standard Deviation 33.2 |
| Transcranial Direct Current Stimulation (tDCS) | Patient Weight | Week3 | 221.9 pound | Standard Deviation 38.5 |
| Transcranial Direct Current Stimulation (tDCS) | Patient Weight | Week4 | 222.8 pound | Standard Deviation 41.6 |
| Transcranial Direct Current Stimulation (tDCS) | Patient Weight | Week5 | 218.7 pound | Standard Deviation 38.4 |
| Transcranial Direct Current Stimulation (tDCS) | Patient Weight | Week6 | 210.7 pound | Standard Deviation 37.8 |
| Transcranial Direct Current Stimulation (tDCS) | Patient Weight | Week7 | 212.6 pound | Standard Deviation 37.6 |
| Transcranial Direct Current Stimulation (tDCS) | Patient Weight | FollowUp-Week1 | 220.8 pound | Standard Deviation 27.5 |
| Transcranial Direct Current Stimulation (tDCS) | Patient Weight | FollowUp-Month1 | 206.2 pound | Standard Deviation 35.5 |
| Chemoradiotherapy Standard of Care | Patient Weight | Week7 | 131.9 pound | — |
| Chemoradiotherapy Standard of Care | Patient Weight | Pre-Study | 136.5 pound | — |
| Chemoradiotherapy Standard of Care | Patient Weight | Week5 | 133 pound | — |
| Chemoradiotherapy Standard of Care | Patient Weight | Week1 | 140 pound | — |
| Chemoradiotherapy Standard of Care | Patient Weight | FollowUp-Month1 | 127.9 pound | — |
| Chemoradiotherapy Standard of Care | Patient Weight | Week2 | 139.3 pound | — |
| Chemoradiotherapy Standard of Care | Patient Weight | Week6 | 132.8 pound | — |
| Chemoradiotherapy Standard of Care | Patient Weight | Week3 | 137.5 pound | — |
| Chemoradiotherapy Standard of Care | Patient Weight | FollowUp-Week1 | 132 pound | — |
| Chemoradiotherapy Standard of Care | Patient Weight | Week4 | 140.6 pound | — |
Secondary
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).
Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-PRE-FollowupMonth1 | 30 score on a scale | Standard Deviation 10 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-POST-PreStudy | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-PRE-Week3 | 11 score on a scale | Standard Deviation 19 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-POST-Week1 | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-PRE-PreStudy | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-POST-Week2 | 14 score on a scale | Standard Deviation 12 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-PRE-Week1 | 19 score on a scale | Standard Deviation 16 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-POST-Week3 | 14 score on a scale | Standard Deviation 14 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-PRE-Week1 | 9 score on a scale | Standard Deviation 8 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-POST-Week4 | 14 score on a scale | Standard Deviation 10 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-PRE-Week4 | 18 score on a scale | Standard Deviation 16 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-POST-Week5 | 14 score on a scale | Standard Deviation 10 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-PRE-Week2 | 7 score on a scale | Standard Deviation 9 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-POST-Week6 | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-PRE-PreStudy | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-POST-Week7 | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-PRE-Week3 | 4 score on a scale | Standard Deviation 8 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-POST-FollowupWeek1 | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-PRE-Week5 | 18 score on a scale | Standard Deviation 16 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-POST-FollowupMonth1 | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-PRE-Week4 | 10 score on a scale | Standard Deviation 6 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-POST-PreStudy | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-PRE-Week2 | 16 score on a scale | Standard Deviation 19 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-POST-Week1 | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-PRE-Week6 | 23 score on a scale | Standard Deviation 13 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-POST-Week2 | 13 score on a scale | Standard Deviation 12 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-PRE-Week6 | 11 score on a scale | Standard Deviation 5 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-POST-Week3 | 14 score on a scale | Standard Deviation 10 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-PRE-Week7 | 10 score on a scale | Standard Deviation 17 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-POST-Week4 | 13 score on a scale | Standard Deviation 10 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-PRE-Week7 | 5 score on a scale | Standard Deviation 9 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GP-PRE-FollowupWeek1 | 21 score on a scale | Standard Deviation 15 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-POST-Week6 | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-PRE-FollowupWeek1 | 10 score on a scale | Standard Deviation 7 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-POST-Week7 | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-POST-Week5 | 14 score on a scale | Standard Deviation 10 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-POST-FollowupWeek1 | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-PRE-Week5 | 9 score on a scale | Standard Deviation 6 |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-POST-FollowupMonth1 | NA score on a scale | — |
| Transcranial Direct Current Stimulation (tDCS) | Positive and Negative Affect Schedule | GN-PRE-FollowupMonth1 | 14 score on a scale | Standard Deviation 5 |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-POST-Week4 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-PRE-Week7 | 37 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-PRE-PreStudy | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-PRE-Week1 | 37 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-PRE-Week2 | 39 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-PRE-Week3 | 38 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-PRE-Week4 | 39 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-PRE-Week5 | 30 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-PRE-FollowupWeek1 | 35 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-PRE-FollowupMonth1 | 38 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-PRE-PreStudy | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-PRE-Week1 | 13 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-PRE-Week2 | 10 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-PRE-Week3 | 10 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-PRE-Week4 | 10 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-PRE-Week5 | 10 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-PRE-Week6 | 10 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-PRE-Week7 | 10 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-PRE-FollowupWeek1 | 10 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-PRE-FollowupMonth1 | 10 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-POST-PreStudy | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-POST-Week1 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-POST-Week2 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-POST-Week3 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-PRE-Week6 | 34 score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-POST-Week5 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-POST-Week6 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-POST-Week7 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-POST-FollowupWeek1 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GP-POST-FollowupMonth1 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-POST-PreStudy | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-POST-Week1 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-POST-Week2 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-POST-Week3 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-POST-Week4 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-POST-Week5 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-POST-Week6 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-POST-Week7 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-POST-FollowupWeek1 | NA score on a scale | — |
| Chemoradiotherapy Standard of Care | Positive and Negative Affect Schedule | GN-POST-FollowupMonth1 | NA score on a scale | — |
Secondary
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.
Time frame: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week4 | 2.0 score on a scale | Standard Deviation 1.4 |
| Transcranial Direct Current Stimulation (tDCS) | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Pre-Study | 0.9 score on a scale | Standard Deviation 1.1 |
| Transcranial Direct Current Stimulation (tDCS) | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week1 | 0.4 score on a scale | Standard Deviation 1 |
| Transcranial Direct Current Stimulation (tDCS) | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week2 | 0.7 score on a scale | Standard Deviation 1 |
| Transcranial Direct Current Stimulation (tDCS) | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week3 | 1.7 score on a scale | Standard Deviation 1 |
| Transcranial Direct Current Stimulation (tDCS) | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week5 | 1.8 score on a scale | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation (tDCS) | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week6 | 1.8 score on a scale | Standard Deviation 0.7 |
| Transcranial Direct Current Stimulation (tDCS) | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week7 | 1.8 score on a scale | Standard Deviation 0.9 |
| Transcranial Direct Current Stimulation (tDCS) | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE FollowUp Week1 | 1.2 score on a scale | Standard Deviation 0.9 |
| Transcranial Direct Current Stimulation (tDCS) | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE FollowUp Month1 | 1.7 score on a scale | Standard Deviation 0.7 |
| Chemoradiotherapy Standard of Care | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week7 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week5 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Pre-Study | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE FollowUp Month1 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week1 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week6 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week2 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE FollowUp Week1 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week3 | 0 score on a scale | — |
| Chemoradiotherapy Standard of Care | Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment | PPI PRE Week4 | 0 score on a scale | — |
Secondary
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.
Time frame: Pre-treatment (baseline), Week 7 of treatment, 1 week and 1 month follow-ups (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Washington Quality Of Life Questionnaire | Pre-Study | 18.6 score on a scale | Standard Deviation 8.3 |
| Transcranial Direct Current Stimulation (tDCS) | Washington Quality Of Life Questionnaire | Week7 | 34.3 score on a scale | Standard Deviation 4.9 |
| Transcranial Direct Current Stimulation (tDCS) | Washington Quality Of Life Questionnaire | FollowUp-Week1 | 31.7 score on a scale | Standard Deviation 6.9 |
| Transcranial Direct Current Stimulation (tDCS) | Washington Quality Of Life Questionnaire | FollowUp-Month1 | 28.6 score on a scale | Standard Deviation 3.5 |
| Chemoradiotherapy Standard of Care | Washington Quality Of Life Questionnaire | FollowUp-Month1 | 10 score on a scale | — |
| Chemoradiotherapy Standard of Care | Washington Quality Of Life Questionnaire | Pre-Study | 20 score on a scale | — |
| Chemoradiotherapy Standard of Care | Washington Quality Of Life Questionnaire | FollowUp-Week1 | 10 score on a scale | — |
| Chemoradiotherapy Standard of Care | Washington Quality Of Life Questionnaire | Week7 | 10 score on a scale | — |