PRIMARY OBJECTIVE:
I. To evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.
SECONDARY OBJECTIVES:
I. To record patient reported outcomes during radiotherapy. II. To evaluate patient narcotic use during radiotherapy. III. To evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3D printed oral stent.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients wear 3D printed oral stent during standard of care radiotherapy.
ARM II: Patients receive standard of care during treatment.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy
Age 18 or older
ECOG PS 0-2
The participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s)
Signed study-specific consent form
You may not be if
Prior head and neck radiotherapy
Participants is unable to fit a tongue-lateralizing or tongue-depressing stent
Severe trismus with an incisal opening of \<10 mm
Inability to comply with the study procedures
Participants younger than 18 years of age
Participants must not be pregnant
Cognitively impaired subjects
Clareo Health | Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
