N/A
N=11
Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer
Cancer of Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT02366611 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Visual Analog Scale (VAS) — 16; 2; 11; 0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Direct Current Stimulation (tDCS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) |
16; 2; 11; 0; 11; 0 | — |
| PRIMARY EEG Power Spectrum Week1/Week7 |
118.9; 111; 115.3; 86.9; 115.4; 74 | — |
| PRIMARY EEG Spectrum Pre-Post tDCS Session |
114.8; 111.0; 109.8; 105.9; 104.5; 115.6 | — |
| SECONDARY Oral-Mucositis Weekly Evaluation - Overall |
4.9; 7; 5; 7; 4.8; 7 | — |
| SECONDARY Patient Weight |
229.2; 136.5; 224.2; 140; 246.2; 139.3 | — |
| SECONDARY Positive and Negative Affect Schedule |
NA; NA; 19; 37; 16; 39 | — |
| SECONDARY Washington Quality Of Life Questionnaire |
18.6; 20; 34.3; 10; 31.7; 10 | — |
| SECONDARY Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment |
0.9; 0; 0.4; 0; 0.7; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02366611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.