A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 119
- 试验地点
- 13
- 主要终点
- Mucositis toxicity rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prior head and neck radiotherapy
- •Participants 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
- •Participants younger than 18 years of age
- •Participants must not be pregnant
- •Cognitively impaired subjects
研究组 & 干预措施
Arm I (3D printed oral stent)
Patients wear 3D printed oral stent during standard of care radiotherapy.
干预措施: Best Practice (Other)
Arm I (3D printed oral stent)
Patients wear 3D printed oral stent during standard of care radiotherapy.
干预措施: Medical Device Usage and Evaluation (Other)
Arm II (standard of care)
Patients receive standard of care during treatment.
干预措施: Best Practice (Other)
Arm II (standard of care)
Patients receive standard of care during treatment.
干预措施: Medical Device Usage and Evaluation (Other)
结局指标
主要结局
Mucositis toxicity rates
时间窗: Through study completion, an average of 1 year
Rate of non-target mucose will be estimated along with the corresponding 95% confidence interval. Cochran-Mantel-Haenszel (CHM) test will be applied to compare mucositis rates between the two treatment arms. Logistic regression will be used to compare occurrence of mucositis between two arms, adjusting for the effects of stratification factors as well as other covariates. T test or Wilcoxon rank sum test will be used to compare three Olerud-Molander Ankle Score between two arms: a mean mucositis score, an extent of mucositis score, and a worst site score.
次要结局
- Patients narcotics diaries(Through study completion, an average of 1 year)
- Imaging difference(Through study completion, an average of 1 year)
- Composite pain scores(Through study completion, an average of 1 year)
- Dosimetric difference(Through study completion, an average of 1 year)
- Number of narcotic pills used(Through study completion, an average of 1 year)
- Patient reported outcomes(Through study completion, an average of 1 year)