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Recruiting NCT04870762

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Phase II Interventional Head and Neck Carcinoma Malignant Parotid Gland Neoplasm Maxillary Sinus Carcinoma Nasal Cavity Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Best Practice, Medical Device Usage and Evaluation.
Who it may be relevant to
Registry conditions: Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma, Nasal Cavity Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Best Practice
    Receive standard of care
  • Other Medical Device Usage and Evaluation
    Wear 3D printed oral stent

Primary outcome measures

  • Mucositis toxicity rates [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (6)
  • Patient reported outcomes [Time frame: Through study completion, an average of 1 year]
  • Patients narcotics diaries [Time frame: Through study completion, an average of 1 year]
  • Imaging difference [Time frame: Through study completion, an average of 1 year]
  • Dosimetric difference [Time frame: Through study completion, an average of 1 year]
  • Composite pain scores [Time frame: Through study completion, an average of 1 year]
  • Number of narcotic pills used [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Banner Health/Banner Research — Phoenix
  • Baptist MD Anderson Cancer Center — Jacksonville
  • Community MD Anderson Cancer Center East — Indianapolis
  • Community MD Anderson Cancer Center South — Indianapolis
  • Community MD Anderson Cancer Center North — Indianapolis
  • Cooper Hospital University Medical Center — Camden
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04870762 · 2020-1153 · NCI-2021-03221 · 2020-1153

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗