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Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
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.
Conditions:
🦠 Head and Neck Carcinoma 🦠 Malignant Parotid Gland Neoplasm 🦠 Maxillary Sinus Carcinoma 🦠 Nasal Cavity Carcinoma 🦠 Oral Cavity Carcinoma 🦠 Tongue Carcinoma 🦠 Tonsillar Carcinoma
🗓️ Study Start (Actual) 26 May 2021
🗓️ Primary Completion (Estimated) 6 November 2024
✅ Study Completion (Estimated) 6 November 2024
👥 Enrollment (Estimated) 93
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Phoenix, Arizona, United States
📍 Jacksonville, Florida, United States
📍 Camden, New Jersey, United States
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 April 2021
  • First Submitted that Met QC Criteria 30 April 2021
  • First Posted 3 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 March 2024
  • Last Update Posted 13 March 2024
  • Last Verified March 2024
I'm interested ...!!