Spots Global Cancer Trial Database for Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

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Trial Identification

Brief Title: Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

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

Study ID: NCT04870762

Conditions

Head and Neck Carcinoma

Malignant Parotid Gland Neoplasm

Maxillary Sinus Carcinoma

Nasal Cavity Carcinoma

Oral Cavity Carcinoma

Tongue Carcinoma

Tonsillar Carcinoma

Interventions

Best Practice

Medical Device Usage and Evaluation

Study Description

Brief Summary: 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.

Detailed Description: 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.