Customized 3D printed oral stents for head and neck cancer patients during radiotherapy
A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents
This study is testing whether custom 3D printed oral stents can help head and neck cancer patients have less mouth pain during radiation treatment compared to those who don’t use them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 119 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Phoenix, Arizona and 6 other locations) |
| Trial ID | NCT04870762 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of customized 3D printed oral stents in reducing acute mucositis rates in patients undergoing radiotherapy for head and neck cancers. Participants are randomized into two groups: one receiving standard radiotherapy with the oral stent and the other receiving standard care without it. The study also aims to assess patient-reported outcomes, narcotic use, and dosimetric differences in treatment. The stents are designed to protect the oral mucosa from radiation-induced damage.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosed head and neck malignancy who are scheduled to receive 5-7 weeks of radiotherapy.
Not a fit: Patients who have previously undergone head and neck radiotherapy or have severe trismus may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of painful mouth sores and improve the quality of life for patients undergoing head and neck radiotherapy.
How similar studies have performed: While the use of 3D printed devices in medical applications is gaining traction, this specific approach to oral stents during radiotherapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 6 other locations
- Banner Health/Banner Research — Phoenix, Arizona, United States (Recruiting)
- Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States (Recruiting)
- Community MD Anderson Cancer Center East — Indianapolis, Indiana, United States (Recruiting)
- Community MD Anderson Cancer Center South — Indianapolis, Indiana, United States (Recruiting)
- Community MD Anderson Cancer Center North — Indianapolis, Indiana, United States (Recruiting)
- Cooper Hospital University Medical Center — Camden, New Jersey, United States (Recruiting)
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Anna Lee — M.D. Anderson Cancer Center
- Study coordinator: Anna Lee, MD
- Email: alee13@mdanderson.org
- Phone: 932-750-1920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.