Clinical Trial Finder

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04870762
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Eugene J Koay
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma, Nasal Cavity Carcinoma, Oral Cavity Carcinoma, Tongue Carcinoma, Tonsillar Carcinoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Arm I (3D printed oral stent)

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

Active Comparator: Arm II (standard of care)

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Banner Health/Banner Research, Phoenix, Arizona

Status

Recruiting

Address

Banner Health/Banner Research

Phoenix, Arizona, 85234

Site Contact

Gary V. Walker, MD

[email protected]

480-256-6444

Baptist MD Anderson Cancer Center, Jacksonville, Florida

Status

Recruiting

Address

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207

Site Contact

Mark E. Augspurger, MD

[email protected]

904-202-7300

Camden, New Jersey

Status

Recruiting

Address

Cooper Hospital University Medical Center

Camden, New Jersey, 08103

Site Contact

Megan Mezera, MD

[email protected]

856-735-6109

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Eugene J. Koay

[email protected]

713-563-2381

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with a healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with site contacts or other relevant parties. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage trial participants to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.