NCT04865731已完成2 期
A Phase II Clinical Trial of Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer Patients (CTMS# 20-0147)
The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年6月15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
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher
研究概览
简要总结
In this study, the study team seek to conduct a pilot clinical study to evaluate the safety and efficacy of a reformulated proton pump inhibitor (PPI) cream (Dermaprazole) in definitive head and neck cancer (HNC) patients.
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
- Single (Outcomes Assessor)
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 with head and neck malignancy (including radiation therapy to primary head cancers of any histology and/or neck lymphatics, excluding brain malignancies)
- •Biopsy proven diagnosis of head and neck malignancy
- •Planned to receive definitive chemoradiation of at least 66Gy
- •Age 18 years or older
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •Written Informed Consent
- •History and Physical within 12 weeks of enrollment
排除标准
- •Prior head and neck radiotherapy
- •Neoadjuvant chemotherapy
- •Any serious medical condition or illness that would preclude the safe administration of the trial treatment including, but not limited to, active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment
- •Currently taking proton pump inhibitors. Eligible if discontinues with physician approval.
- •Lack of concurrent chemotherapy
- •Open wound at time of simulation
- •Known autoimmune, connective tissue, or skin disorder; or other theoretical radiosensitivity to include bullous pemphigoid, dermatomyositis, lupus of the skin and scleroderma
研究组 & 干预措施
Dermaprazole
Experimental
30 HNC patients who will be using Dermaprazole twice daily for 7 weeks
干预措施: Dermaprazole (Drug)
Aquaphor
Active Comparator
15 HNC patients using Aquaphor, the current clinical standard of care
干预措施: Aquaphor (Drug)
结局指标
主要结局
Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher
时间窗: 15 months
Number of radiation dermatitis adverse events defined by the NCI CTCAE version 5 that are graded as 2 or higher
次要结局
未报告次要终点
研究者
研究点 (1)
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