NCT07076914尚未招募2 期
Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy: A Randomized Clinical Trial
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年10月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Worst patient-reported esophageal pain score during radiation
研究概览
简要总结
A randomized controlled trial to assess the impact of prophylactic proton pump inhibitor use to improve esophagitis in lung cancer patients undergoing radiation. Patients will be randomized into a standard of care arm or the prophylactic proton pump (daily) arm.
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
- •Age 18 years or older
- •Willing to provide informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •Life expectancy of at least 3 months
- •Primary lung malignancy of any stage (including NSCLC and small cell lung cancer). Histologic/pathologic diagnosis is preferred, but not required.
- •Receiving a prescribed dose of at least 40 Gy in 15 fractions (or equivalent). Eligible fractionations include, but are not limited to, 60 Gy in 30 fractions, 55 Gy in 20 fractions, and 40-45 Gy in 15 fractions.
- •On radiation planning, at least 5 cc of esophagus is receiving at least 95% of prescription dose
排除标准
- •• Serious medical comorbidities precluding radiotherapy
- •Use of PPI within 3 months prior to enrollment
- •Allergy to PPI
- •Odynophagia (painful swallowing) prior to enrollment
- •Pregnant or lactating women
- •Note: previous radiation to the thorax is allowed, as long as the composite plan of current and prior radiation doses meet standard institutional dose constraints, in the opinion of the treating radiation oncologist.
研究组 & 干预措施
Prophylactic Proton Pump Inhibitor
Experimental
Daily use of pantoprazole magnesium, rabeprazole or lansoprazole
干预措施: Experimental (Health Canada Approved Proton Pump Inhibitors) (Drug)
结局指标
主要结局
Worst patient-reported esophageal pain score during radiation
时间窗: baseline last week of radiation post-treatment
Assessed with the 11-Numeric Rating Scale using weekly questionnaires
次要结局
未报告次要终点
研究者
David Palma
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
研究点 (1)
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