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NCT04870762 | RECRUITING | Head and Neck Carcinoma

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

M.D. Anderson Cancer Center

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.

Condition or disease

Head and Neck Carcinoma

Malignant Parotid Gland Neoplasm

Maxillary Sinus Carcinoma

Nasal Cavity Carcinoma

Oral Cavity Carcinoma

Tongue Carcinoma

Tonsillar Carcinoma

Intervention/treatment

Best Practice

Medical Device Usage and Evaluation

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 119 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents
Actual Study Start Date : 2021-05-26
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Location Details

NCT04870762

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Banner Health/Banner Research

Phoenix, Arizona, United States, 85234

RECRUITING

United States, Florida

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States, 32207

RECRUITING

United States, Indiana

Community MD Anderson Cancer Center East

Indianapolis, Indiana, United States, 46219

RECRUITING

United States, Indiana

Community MD Anderson Cancer Center South

Indianapolis, Indiana, United States, 46227

RECRUITING

United States, Indiana

Community MD Anderson Cancer Center North

Indianapolis, Indiana, United States, 46250

RECRUITING

United States, New Jersey

Cooper Hospital University Medical Center

Cam, New Jersey, United States, 08103

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030