RECRUITING

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-05-26
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04870762

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy
  2. * Age 18 or older
  3. * ECOG PS 0-2
  4. * The participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s)
  5. * Signed study-specific consent form
  1. * Prior head and neck radiotherapy
  2. * Participants is unable to fit a tongue-lateralizing or tongue-depressing stent
  3. * Severe trismus with an incisal opening of \<10 mm
  4. * Inability to comply with the study procedures
  5. * Participants younger than 18 years of age
  6. * Participants must not be pregnant
  7. * Cognitively impaired subjects

Contacts and Locations

Study Contact

Anna Lee, MD
CONTACT
932-750-1920
alee13@mdanderson.org

Principal Investigator

Anna Lee
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

Banner Health/Banner Research
Phoenix, Arizona, 85234
United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Anna Lee, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-26
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-05-26
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Carcinoma
  • Malignant Parotid Gland Neoplasm
  • Maxillary Sinus Carcinoma
  • Nasal Cavity Carcinoma
  • Oral Cavity Carcinoma
  • Tongue Carcinoma
  • Tonsillar Carcinoma