Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 7
- 主要终点
- Accrual rate (Two-stage consent part)
研究概览
简要总结
The purpose of the study is to explore options for preventing and reducing symptoms of radiation esophagitis (RE). The researchers will also look what symptoms participants experience, and whether there are differences in weight loss in participants.
详细描述
Embedded Randomized Study to Assess Two-Stage Consent Design:
There will be two separate randomizations in this study, one vs. two-stage consent and sucralfate vs. control. The will first approach patients and explain that we are comparing different methods of informing patients about trials. If the patients do not wish to participate in the consent trial, participants will be approached for consent onto the therapeutic trial using the twostage research consent.
Patients who decline or who are not approached to take part in the randomized compression of consent methods based on physician discretion, may still take part in the randomized comparison of sucralfate vs. control (therapeutic trial).
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
- •Patients being treated with thoracic irradiation with high-risk esophageal dose as determined below:
- •Esophageal dose:
- •V50 ≥ 15% (25-35 once daily fractions) or 40 twice-daily [BID] fractions)
- •V40 ≥ 15% (15-24 once daily fractions or 30 twice-daily [BID] fractions)
- •V30 ≥ 15% (10-14 once daily fractions)
- •Age 18 years of age or older.
排除标准
- •Known inability to take Sucralfate (tablet and/or suspension form), per physician discretion
- •Actively taking any opioid pain medications prior to radiation therapy
- •History of an opioid use disorder
研究组 & 干预措施
One Stage Consent
Patient will sign one consent form.
干预措施: One consent (Other)
Two Stage Consent
Patient will sign two consent forms.
干预措施: Two consent (Other)
Sucralfate
During their RT course, patients randomized to the PS arm will receive a prescription for either: 1) sucralfate, 1 gram/10 mL oral suspension or 2) sucralfate 1 gram tablets.
干预措施: Sucralfate (Drug)
Usual Care
Standard supportive care by using opioids.
干预措施: Usual Care (Other)
结局指标
主要结局
Accrual rate (Two-stage consent part)
时间窗: 1 year
Determine accrual rate of two-stage consent compared to standard onestage consent.
Reduce opioid use
时间窗: 2 years
as measured by documented opioid use within the past 24 hours in the EMR at time of final weekly status check
次要结局
未报告次要终点