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3D Printed Stents for Head and Neck Cancer

N/A

Waitlist Available

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

Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2

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

Must not have

Severe trismus with an incisal opening of < 10 mm

Prior head and neck radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a 3D-printed stent to a dentist-made stent to help patients with head and neck cancer during radiation therapy with fewer appointments and lower cost.

Who is the study for?

This trial is for patients with head and neck cancer who need an oral stent as part of their radiation therapy. They must be treated at MD Anderson Cancer Center, have a performance status score of 0-2, consent to the study, and have pre-treatment imaging that includes their teeth. Patients with prior head and neck radiotherapy or severe trismus are excluded.

What is being tested?

The trial is testing a customized 3D-printed oral stent against traditional dentist-made stents in patients receiving radiation therapy for head and neck cancer. The focus is on comparing effectiveness in preventing side effects and efficiency in turnaround time for device delivery.

What are the potential side effects?

While this trial primarily focuses on the efficacy of the stent devices rather than medication, potential discomforts may include issues related to wearing an oral device such as irritation inside the mouth or difficulty speaking or swallowing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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I am set to receive radiotherapy for my head or neck cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can barely open my mouth (less than 10mm).

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I have had radiotherapy for head or neck cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate whether a customized 3 dimensional (3D) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 3D printed stent+ MDASI-3D Oral Stents QuestionnaireExperimental Treatment2 Interventions

Patients wear a customized 3D printed oral stent over 5-10 minutes in the supine position at the time of radiation simulation, before starting radiation therapy, and in the 3rd to 5th week of radiation therapy. Patients may also optionally wear the commercially-made stent called TruGuard at these timepoints. Ancillary Studies (MDASI-3D Oral Stents Questionnaire)

0 / 4Eligibility criteria met