A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- % of Participants With Grade 2 Rash or Higher
研究概览
简要总结
This randomized, controlled, phase II clinical study is designed to assess the efficacy of preemptive treatment with topical steroids in preventing the papulopustular eruption induced by epidermal growth factor receptor inhibitor (EGFRI) treatment in cancer patients. Participants will be followed up for 6 weeks of twice daily application of triamcinolone cream to the face, chest, and back.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 must have a histologically or cytologically confirmed cancer diagnosis for which EGFRI treatment is indicated
- •Initiation of topical steroids or control treatment within 3 days of initiation of cetuximab, erlotinib, panitumumab, or afatinib
- •Patients must be age ≥ 18 years.
- •Life expectancy of greater than 6 weeks
- •Patient able to use topical medications reliably and complete questionnaires with assistance if needed
- •Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.
排除标准
- •Patients who have used systemic or topical steroids within 7 days of trial registration, or start systemic or topical steroids for reasons unrelated to trial during the 6-week follow up period
- •Patients who have used antibiotics within 7 days of trial registration, or start antibiotics for other conditions during the 6-week follow up period
- •History of allergic reactions to topical steroids
- •Patients with any rash at the time of study registration
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients using any other topical medications in the treatment areas (face, chest, or back).
研究组 & 干预措施
Triamcinolone
Patients in the Triamcinolone group will be applying Triamcinolone 0.1% cream daily to their face, chest, and upper back, in addition to adhering to the same daily moisturizer and sunscreen regimen of the Control group. Erlotinib, cetuximab, panitumumab, or afatinib will be administered concomitantly as standard of care treatment.
干预措施: Triamcinolone (Drug)
结局指标
主要结局
% of Participants With Grade 2 Rash or Higher
时间窗: 6 weeks
To assess the difference in percentage of participants who develop a grade 2 or greater rash in the control group as compared to the case group of preemptive treatment with topical steroids (triamcinolone 0.1% cream for application to face, chest and back) when administered concomitantly for 6 weeks with erlotinib, cetuximab, panitumumab, or afatinib to prevent papulopustular eruptions.
次要结局
- Change in Quality of Life Using FACT-EGFRI 18 Quality of Life Assessment(6 weeks)
- Number of Participants in the Treatment and Control Group Who Adhere to Their Chemotherapy Regimen Determined by Whether Patients Discontinue Their Chemotherapy Regimen or Continue Their Full Course of Treatment(6 weeks)
研究者
Jennifer Nam Choi, MD
Chief of Oncodermatology
Northwestern University