Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Malignant Parotid Gland Neoplasm; Tongue Carcinoma; Head and Neck Carcinoma; Oral Cavity Carcinoma; Nasal Cavity Carcinoma; Maxillary Sinus Carcinoma; Tonsillar Carcinoma

Treatments: Other: Best Practice; Other: Medical Device Usage and Evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT04870762

2020-1153

NCI-2021-03221 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Arm I (3D printed oral stent)

Experimental group

Description:

Patients wear 3D printed oral stent during standard of care radiotherapy.

Treatment:

Other: Medical Device Usage and Evaluation

Other: Best Practice

Arm II (standard of care)

Active Comparator group

Description:

Patients receive standard of care during treatment.

Treatment:

Other: Medical Device Usage and Evaluation

Other: Best Practice