Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer
Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Locally Advanced Head and Neck Cancer
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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).
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Michigan
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Ann Arbor, Michigan, Egyesült Államok, 48106
- University of Michigan
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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.
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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.
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Nincs beavatkozás: Chemoradiotherapy Standard of Care
The control group will consist of patients receiving the Standard of care and no neuromodulation.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Visual Analog Scale (VAS)
Időkeret: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
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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.
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Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
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EEG Power Spectrum Week1/Week7
Időkeret: Week1/Week7
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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:
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. |
Week1/Week7
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EEG Spectrum Pre-Post tDCS Session
Időkeret: Pre/Post-tDCS Session
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EEG data power spectrum analysis. Pre/Post-tDCS session. The report was divided into five frequency bands:
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. |
Pre/Post-tDCS Session
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Oral-Mucositis Weekly Evaluation - Overall
Időkeret: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
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1-7 scale grading self-evaluated overall physical condition, 7= Excellent, 1 = Very poor.
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Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
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Patient Weight
Időkeret: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
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Participant's weight each measurement time point.
Note: 0 means data missing.
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Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
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Positive and Negative Affect Schedule
Időkeret: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
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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).
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Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
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Washington Quality Of Life Questionnaire
Időkeret: Pre-treatment (baseline), Week 7 of treatment, 1 week and 1 month follow-ups (post-treatment)
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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.
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Pre-treatment (baseline), Week 7 of treatment, 1 week and 1 month follow-ups (post-treatment)
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Present Pain Intensity Index in McGill Questionnaire Pre-tDCS Treatment
Időkeret: Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
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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.
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Pre-treatment (baseline), throughout treatment (once a week for 7 weeks), 1 week and 1 month follow-ups (post-treatment)
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Alexandre DaSilva, DDS, DMedSc, University of Michigan
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- HUM 78942
- U036889 (Egyéb azonosító: UMichigan)
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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