Идёт набор NCT04870762

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Фаза II С лечением Head and Neck Carcinoma Malignant Parotid Gland Neoplasm Maxillary Sinus Carcinoma Nasal Cavity Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Best Practice, Medical Device Usage and Evaluation.
Кому может быть актуально: Состояния в реестре: Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma, Nasal Cavity Carcinoma. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents

Обзор

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.

Подробное описание

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.

Вмешательства

Другое Best Practice
Receive standard of care
Другое Medical Device Usage and Evaluation
Wear 3D printed oral stent

Первичные конечные точки

Mucositis toxicity rates [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (6)

Patient reported outcomes [Срок оценки: Through study completion, an average of 1 year]
Patients narcotics diaries [Срок оценки: Through study completion, an average of 1 year]
Imaging difference [Срок оценки: Through study completion, an average of 1 year]
Dosimetric difference [Срок оценки: Through study completion, an average of 1 year]
Composite pain scores [Срок оценки: Through study completion, an average of 1 year]
Number of narcotic pills used [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

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