Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents

This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving radiotherapy. Oral stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy. A customized, 3D-printed oral stent may help to reduce mouth blisters and/or sores that may develop in patients while receiving head and neck radiation therapy.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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