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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,724 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,096 Total Patients Enrolled

Eugene J KoayPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

273 Total Patients Enrolled

Media Library

3D printed stent+ MDASI-3D Oral Stents Questionnaire Clinical Trial Eligibility Overview. Trial Name: NCT05126797 — N/A

Head and Neck Cancers Research Study Groups: 3D printed stent+ MDASI-3D Oral Stents Questionnaire

Head and Neck Cancers Clinical Trial 2023: 3D printed stent+ MDASI-3D Oral Stents Questionnaire Highlights & Side Effects. Trial Name: NCT05126797 — N/A

3D printed stent+ MDASI-3D Oral Stents Questionnaire 2023 Treatment Timeline for Medical Study. Trial Name: NCT05126797 — N/A

Frequently Asked Questions

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

Are any new participants being accepted into this experiment?

"According to the clinicaltrials.gov web page, this therapeutic trial is no longer looking for patients as it was last modified on October 14th 2022. Despite that, there are 395 other research studies currently recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

3D Printed Oral Stents for Patients With Head and Neck Cancer Receiving Radiation Therapy

2017. "3D Printed Oral Stents for Patients With Head and Neck Cancer Receiving Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05126797.