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

  • STATUS
    Recruiting
  • End date
    Nov 6, 2024
  • participants needed
    93
  • sponsor
    M.D. Anderson Cancer Center
Updated on 23 October 2022

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.

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.

Details
Condition Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma, Nasal Cavity Carcinoma, Oral Cavity Carcinoma, Tongue Carcinoma, Tonsillar Carcinoma
Treatment Best Practice, Medical Device Usage and Evaluation
Clinical Study IdentifierNCT04870762
SponsorM.D. Anderson Cancer Center
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy that includes
Well lateralized tonsil cancer with no soft palate involvement and qualifies for ipsilateral radiotherapy
Well lateralized buccal cancer that qualifies for ipsilateral radiotherapy
Well lateralized parotid cancer that qualifies for ipsilateral radiotherapy
A cancer that involves the nasal cavity and does not require coverage of the oral cavity or oropharynx
A cancer that involves the maxillary sinus and does not require coverage of the oral cavity or oropharynx
A cancer that involves the base of tongue
Age 18 or older
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
The patient will receive radiotherapy with either cisplatin, carboplatin, or cetuximab
Signed study-specific consent form

Exclusion Criteria

Prior head and neck radiotherapy
Patient 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
Patients younger than 18 years of age
Patients must not be pregnant
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