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3D Printed Oral Stents for Head and Neck Cancers

Phase 2
Recruiting
Led By Eugene J Koay
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient will receive radiotherapy with either cisplatin, carboplatin, or cetuximab
- A cancer that involves the maxillary sinus and does not require coverage of the oral cavity or oropharynx
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial looks at whether 3D-printed oral tents can help reduce mouth blisters and sores for patients receiving head and neck radiation therapy.

Who is the study for?
This trial is for adults with specific head and neck cancers, including those affecting the tongue, nasal cavity, maxillary sinus, tonsils, buccal region or parotid gland. Participants must be receiving radiotherapy with cisplatin, carboplatin or cetuximab and have a performance status that allows daily activities. Those who've had prior head and neck radiation or can't use oral stents due to severe mouth opening limitations are excluded.Check my eligibility
What is being tested?
The study evaluates customized 3D-printed oral stents in patients undergoing radiotherapy for head and neck cancer. These personalized devices aim to protect teeth and gums during treatment potentially reducing mouth sores caused by radiation.See study design
What are the potential side effects?
While not directly related to side effects of medication, using an oral stent may cause discomfort or irritation in the mouth. There's also a potential risk of increased salivation or gagging when wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will be treated with radiotherapy and either cisplatin, carboplatin, or cetuximab.
Select...
My cancer is in the maxillary sinus and doesn't affect my mouth or throat.
Select...
My cancer is located at the base of my tongue.
Select...
I will be treated with radiotherapy and either cisplatin, carboplatin, or cetuximab.
Select...
I am 18 years old or older.
Select...
My cancer is located in my nasal cavity and does not affect my mouth or throat.
Select...
I am 18 years old or older.
Select...
I am able to get out of my bed or chair and move around.
Select...
My tonsil cancer is on one side without affecting the soft palate and qualifies for one-sided radiotherapy.
Select...
My parotid cancer is on one side and qualifies for targeted radiation therapy.
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I am able to get out of my bed or chair and move around.
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My cheek cancer is on one side and qualifies for targeted radiation therapy.
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My cheek cancer is on one side and qualifies for targeted radiation therapy.
Select...
I have a specific type of throat cancer and am set to receive targeted radiation therapy.
Select...
My parotid cancer is on one side and qualifies for targeted radiation therapy.
Select...
My cancer affects the maxillary sinus but not my mouth or throat.
Select...
My cancer is located at the base of my tongue.
Select...
I am set to receive radiotherapy for my head or neck cancer.
Select...
My cancer is in the nasal cavity and doesn't affect my mouth or throat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mucositis toxicity rates
Secondary outcome measures
Composite pain scores
Dosimetric difference
Imaging difference
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (3D printed oral stent)Experimental Treatment2 Interventions
Patients wear 3D printed oral stent during standard of care radiotherapy.
Group II: Arm II (standard of care)Active Control2 Interventions
Patients receive standard of care during treatment.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,272 Total Patients Enrolled
Eugene J KoayPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
237 Total Patients Enrolled

Media Library

Medical Device Usage and Evaluation Clinical Trial Eligibility Overview. Trial Name: NCT04870762 — Phase 2
Head and Neck Cancers Research Study Groups: Arm I (3D printed oral stent), Arm II (standard of care)
Head and Neck Cancers Clinical Trial 2023: Medical Device Usage and Evaluation Highlights & Side Effects. Trial Name: NCT04870762 — Phase 2
Medical Device Usage and Evaluation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04870762 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the participant base of this clinical study?

"Affirmative. Clinicaltrials.gov records support the assertion that, as of October 10th 2022, this trial is still in need of 93 participants from 4 sites. The study was initially published on May 26 2021 and has been modified since then."

Answered by AI

How many venues are there for participating in this clinical investigation?

"This clinical trial is currently being managed from Banner Health/Banner Research in Phoenix, Arizona; M D Anderson Cancer Center in Houston, Texas; Cooper Hospital University Medical Center in Camden, New jersey; and four other establishments."

Answered by AI

Are there any opportunities for participants to take part in this medical experiment?

"According to the clinicaltrials.gov website, this experiment is still recruiting participants; it was first published on May 26th 2021 and its details were modified lastly on October 10th 2022."

Answered by AI
~16 spots leftby Nov 2024