An Exploratory, Placebo-Controlled Trial of Prophylactic Tetracycline for Gefitinib-or Cetuximab-Induced Skin Rash (or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Skin Rash)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 69
- 主要终点
- Rash severity
研究概览
简要总结
RATIONALE: Tetracycline may be effective in preventing skin rash that is caused by treatment with drugs such as gefitinib or cetuximab.
PURPOSE: This randomized clinical trial is studying tetracycline to see how well it works compared to placebo in preventing skin rash in patients who are receiving drugs such as gefitinib or cetuximab for cancer.
详细描述
OBJECTIVES:
- Compare the 1-month incidence and severity of gefitinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with tetracycline vs placebo.
- Compare the toxicity of these drugs in these patients.
- Compare the quality of life of patients treated with these drugs who develop vs those who do not develop a rash.
- Determine whether patients who discontinue tetracycline at 1 month develop a rash.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior chemotherapy regimen (first-line therapy vs other), concurrent epidermal growth factor receptor inhibitor therapy (gefitinib vs cetuximab vs other), and concurrent corticosteroid therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tetracycline twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 4 weeks in the absence of unacceptable toxicity.
Quality of life is assessed at baseline and then weekly for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
tetracycline
Patients receive oral tetracycline twice daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity.
Quality of life is assessed at baseline and then weekly for 8 weeks.
Patients are followed at weeks 4 and 8.
干预措施: tetracycline hydrochloride (Drug)
placebo
Patients receive oral placebo twice daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity.
Quality of life is assessed at baseline and then weekly for 8 weeks.
Patients are followed at weeks 4 and 8.
干预措施: placebo (Other)
结局指标
主要结局
Rash severity
时间窗: Up to 8 weeks
1-month incidence and severity
时间窗: Up to 8 weeks
次要结局
- quality of life(Up to 8 weeks)