Clinical trial NCT04870762: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head and Neck Carcinoma
Malignant Parotid Gland Neoplasm
Maxillary Sinus Carcinoma
Nasal Cavity Carcinoma
Oral Cavity Carcinoma
Tongue Carcinoma
Tonsillar Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mucositis toxicity rates
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Patient reported outcomes
timeFrame: Through study completion, an average of 1 year
measure: Patients narcotics diaries
timeFrame: Through study completion, an average of 1 year
measure: Imaging difference
timeFrame: Through study completion, an average of 1 year
measure: Dosimetric difference
timeFrame: Through study completion, an average of 1 year
measure: Composite pain scores
timeFrame: Through study completion, an average of 1 year
measure: Number of narcotic pills used
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Health/Banner Research
state: Arizona
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Indianapolis
country: United States
facility: Community MD Anderson Cancer Center East
state: Indiana
city: Indianapolis
country: United States
facility: Community MD Anderson Cancer Center South
state: Indiana
city: Indianapolis
country: United States
facility: Community MD Anderson Cancer Center North
state: Indiana
city: Camden
country: United States
facility: Cooper Hospital University Medical Center
state: New Jersey
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Anna Lee
role: PRINCIPAL_INVESTIGATOR
References: