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.
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)
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
Parallel
Best Practice
Other interventionReceive standard of care
Medical Device Usage and Evaluation
Other interventionWear 3D printed oral stent
Mucositis toxicity rates
Rate of non-target mucose will be estimated along with the corresponding 95% confidence interval. Cochran-Mantel-Haenszel (CHM) test will be applied to compare mucositis rates between the two treatment arms. Logistic regression will be used to compare occurrence of mucositis between two arms, adjusting for the effects of stratification factors as well as other covariates. T test or Wilcoxon rank sum test will be used to compare three Olerud-Molander Ankle Score between two arms: a mean mucositis score, an extent of mucositis score, and a worst site score.
Patient reported outcomes
Will be assessed using the MD Anderson Symptom Inventory Head and Neck questionnaire. T test or Wilcoxon rank sum test will be used to compare scores of each item per time point or sums of scores across all items at each time point or sums across three time point per item between the two arms. Multivariate analyses such as linear regression model adjusting for the effects of covariates might be performed to compare patients reported outcomes. Appropriate data transformation will be performed if necessary for assumption of normality.
Patients narcotics diaries
Will record the worst, the least, the average pain score and pain score at present for each day. Will calculate the average of these 4 scores as a composite daily pain score.
Imaging difference
The set up error during radiation will be measured in each treatment arm.
Dosimetric difference
The radiation dose to healthy tissue will be measured in each treatment arm.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
