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New treatment option for Head and Neck Carcinoma
Official title Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
ClinicalTrials.gov ID: NCT04870762
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 people
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Indianapolis, Indiana, United States
- Camden, New Jersey, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Indianapolis, Indiana, United States; Camden, New Jersey, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.