Using an intraoral stent to improve radiotherapy for head and neck cancer
Patient-reported Outcome After Radiotherapy of Oral Cavity and Sinonasal Cancer Using an Intraoral Stent
PHASE2 · Oslo University Hospital · NCT04330781
This study is testing whether an intraoral stent can help people with head and neck cancer during radiotherapy by making treatment easier and reducing side effects.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Drugs / interventions | Radiation |
| Locations | 1 site (Oslo) |
| Trial ID | NCT04330781 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of an intraoral stent during radiotherapy for patients with oral cavity and sinonasal cancers. The stent is designed to create a larger distance between the tongue and palate, potentially reducing the side effects associated with radiation treatment. Following a successful pilot study, this phase 2 trial aims to confirm that the stent does not significantly bother patients while also reducing radiation exposure to sensitive areas. Participants will be monitored for symptoms throughout their treatment period.
Who should consider this trial
Good fit: Ideal candidates include patients with oral cavity or sinonasal cancers who are scheduled to receive a radiation dose of 30 Gy or higher.
Not a fit: Patients with a performance status above ECOG 3 or those unable to understand and answer questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved comfort and reduced side effects for patients undergoing radiotherapy for head and neck cancers.
How similar studies have performed: Previous pilot studies have shown promising results with the use of intraoral stents in similar patient populations, indicating potential for success in this larger trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Radiation dose 30 Gy or higher * Cancer in the inferior part of the oral cavity (e.g. tongue or floor of mouth cancer) or superior part of the oral cavity (e.g. hard palate) or sinonasal cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 * Ability to understand and answer questionnaire Exclusion Criteria: None
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (RECRUITING)
Study contacts
- Principal investigator: Einar Dale, MD PhD — Senior Consultant
- Study coordinator: Einar Dale, MD PhD
- Email: eindal@ous-hf.no
- Phone: +4722934000
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.
Conditions: Oral Cavity Cancer, Sinonasal Cancer, Radiotherapy, Intraoral stent, Head and neck cancer, Patient-reported outcome