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Clinical Trials/NCT04870762
NCT04870762RecruitingPhase 2

A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents

M.D. Anderson Cancer Center13 sites in 1 country119 target enrollmentStarted: May 26, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
119
Locations
13
Primary Endpoint
Mucositis toxicity rates

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Arm I (3D printed oral stent)

Experimental

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

Intervention: Best Practice (Other)

Arm I (3D printed oral stent)

Experimental

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

Intervention: Medical Device Usage and Evaluation (Other)

Arm II (standard of care)

Active Comparator

Patients receive standard of care during treatment.

Intervention: Best Practice (Other)

Arm II (standard of care)

Active Comparator

Patients receive standard of care during treatment.

Intervention: Medical Device Usage and Evaluation (Other)

Outcomes

Primary Outcomes

Mucositis toxicity rates

Time Frame: Through study completion, an average of 1 year

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.

Secondary Outcomes

  • Patients narcotics diaries(Through study completion, an average of 1 year)
  • Imaging difference(Through study completion, an average of 1 year)
  • Composite pain scores(Through study completion, an average of 1 year)
  • Dosimetric difference(Through study completion, an average of 1 year)
  • Number of narcotic pills used(Through study completion, an average of 1 year)
  • Patient reported outcomes(Through study completion, an average of 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (13)

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