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Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Primary Purpose

Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Medical Device Usage and Evaluation
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy that includes

    • Well lateralized tonsil cancer with no soft palate involvement and qualifies for ipsilateral radiotherapy
    • Well lateralized buccal cancer that qualifies for ipsilateral radiotherapy
    • Well lateralized parotid cancer that qualifies for ipsilateral radiotherapy
    • A cancer that involves the nasal cavity and does not require coverage of the oral cavity or oropharynx

    • A cancer that involves the maxillary sinus and does not require coverage of the oral cavity or oropharynx

      • A cancer that involves the base of tongue
  • Age 18 or older
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • The patient will receive radiotherapy with either cisplatin, carboplatin, or cetuximab
  • Signed study-specific consent form

Exclusion Criteria:

  • Prior head and neck radiotherapy
  • Patient 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
  • Patients younger than 18 years of age
  • Patients must not be pregnant

Sites / Locations

  • Banner Health/Banner ResearchRecruiting
  • Baptist MD Anderson Cancer CenterRecruiting
  • Cooper Hospital University Medical CenterRecruiting
  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (3D printed oral stent)

Arm II (standard of care)

Arm Description

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

Patients receive standard of care during treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Composite pain scores
An area under curve of pain scores over two weeks (AUC2wks) will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms. The linear mixed models will also be fitted to evaluate the association of composite pain scores with occurrence of their non-target mucosa.
Number of narcotic pills used
An AUC2wks will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms.

Full Information

First Posted
April 23, 2021
Last Updated
September 5, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04870762
Brief Title
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Official Title
A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
November 6, 2024 (Anticipated)
Study Completion Date
November 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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. ARM I: Patients wear 3D printed oral stent during standard of care radiotherapy. ARM II: Patients receive standard of care during treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma, Nasal Cavity Carcinoma, Oral Cavity Carcinoma, Tongue Carcinoma, Tonsillar Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (3D printed oral stent)
Arm Type
Experimental
Arm Description
Patients wear 3D printed oral stent during standard of care radiotherapy.
Arm Title
Arm II (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care during treatment.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Other
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Wear 3D printed oral stent
Primary Outcome Measure Information:
Title
Mucositis toxicity rates
Description
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.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Patient reported outcomes
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Patients narcotics diaries
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Imaging difference
Description
The set up error during radiation will be measured in each treatment arm.
Time Frame
Through study completion, an average of 1 year
Title
Dosimetric difference
Description
The radiation dose to healthy tissue will be measured in each treatment arm.
Time Frame
Through study completion, an average of 1 year
Title
Composite pain scores
Description
An area under curve of pain scores over two weeks (AUC2wks) will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms. The linear mixed models will also be fitted to evaluate the association of composite pain scores with occurrence of their non-target mucosa.
Time Frame
Through study completion, an average of 1 year
Title
Number of narcotic pills used
Description
An AUC2wks will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy that includes Well lateralized tonsil cancer with no soft palate involvement and qualifies for ipsilateral radiotherapy Well lateralized buccal cancer that qualifies for ipsilateral radiotherapy Well lateralized parotid cancer that qualifies for ipsilateral radiotherapy A cancer that involves the nasal cavity and does not require coverage of the oral cavity or oropharynx A cancer that involves the maxillary sinus and does not require coverage of the oral cavity or oropharynx A cancer that involves the base of tongue Age 18 or older Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 The patient will receive radiotherapy with either cisplatin, carboplatin, or cetuximab Signed study-specific consent form Exclusion Criteria: Prior head and neck radiotherapy Patient 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 Patients younger than 18 years of age Patients must not be pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eugene Koay, MD
Phone
(713) 792-9149
Email
ekoay@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene J Koay
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Health/Banner Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary V. Walker, MD
Phone
480-256-6444
Email
gary.walker@bannerhealth.com
First Name & Middle Initial & Last Name & Degree
Gary V. Walker, MD
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark E. Augspurger, MD
Phone
904-202-7300
Email
mark.augspurger@bmcjax.com
First Name & Middle Initial & Last Name & Degree
Mark E. Augspurger, MD
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Mezera, MD
Phone
856-735-6109
Email
mezera-megan@cooperhealth.edu
First Name & Middle Initial & Last Name & Degree
Megan Mezera, MD
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene J. Koay
Phone
713-563-2381
Email
ekoay@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Eugene J. Koay

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

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Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

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