NCT03427021终止早期 1 期
A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- overall intraoral cold sensitivity score
研究概览
简要总结
The main purpose of this study is to evaluate whether exposure to ice chips in the mouth (oral ice chips) during oxaliplatin treatment prevents or reduces symptoms of cold sensitivity.
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
- •Individuals ≥18 years of age will be enrolled.
- •Patients must have histologic confirmation of a solid tumor malignancy that will be treated with a regimen that contains full-dose oxaliplatin.
- •Patients may be receiving treatment in the neoadjuvant, adjuvant or metastatic setting.
- •Patients must be treatment-naïve to platinum-agents at the time of enrollment. Prior treatment with non-platinum agents is permitted.
排除标准
- •Any active intraoral infection, including yeast infection (thrush) or active oral herpes simplex virus at the time of enrollment.
- •Patients may not have dentures.
- •Patients may not have a disorder that may result in altered taste sensation at baseline. This includes but is not limited to: persistent dry mouth.
研究组 & 干预措施
Arm A
Experimental
will be treated with consistent exposure to oral ice
干预措施: Oxaliplatin (Drug)
Arm B
Active Comparator
Will not be treated with consistent exposure to oral ice.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
overall intraoral cold sensitivity score
时间窗: a minimum of four cycles (2 months) and a maximum of 12 cycles (6 months)
graded 0 to 4
次要结局
未报告次要终点
研究者
研究点 (1)
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