A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period
研究概览
简要总结
RATIONALE: The use of a nicotine inhaler may help decrease appetite and relieve "hunger pain" (an intense craving for food) in patients with malignant bowel obstruction caused by cancer.
PURPOSE: This randomized clinical trial is studying the side effects and how well a nicotine inhaler works in treating "hunger pain" in patients with malignant bowel obstruction caused by cancer.
详细描述
OBJECTIVES:
- Determine whether patients with malignant bowel obstruction due to incurable cancer utilize a potential therapy for "hunger pain."
- Determine, preliminarily, the efficacy and toxicity of nicotine in treating "hunger pain" in these patients.
- Determine whether nicotine results in a decline in circulating ghrelin (for patients enrolled at the Mayo Rochester Clinic only).
- Evaluate hormonal changes in patients treated with nicotine (for patients enrolled at the Mayo Rochester Clinic only).
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter, pilot study. Patients are stratified according to vomiting status within the past 24 hours (yes vs no) and use of narcotics (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive a nicotine inhaler to use as needed for "hunger pain." Treatment continues for up to 48 hours in the absence of unacceptable toxicity .
- Arm II: Patients receive a placebo inhaler to use as needed for "hunger pain." Treatment continues for up to 48 hours in the absence of unacceptable toxicity.
After 48 hours, patients in arm I may continue nicotine therapy off study. Patients in arm II who are not surgical candidates may cross over to treatment with the nicotine inhaler off study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
Nicotine inhaler
干预措施: nicotine (Drug)
Nicotine inhaler
干预措施: Quality of life (Procedure)
Placebo inhaler
干预措施: Placebo (Other)
Placebo inhaler
干预措施: Quality of life (Procedure)
结局指标
主要结局
Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period
时间窗: 48 Hours
次要结局
- Toxicity as measured by CTCAE v 2.0(48 hours)
- Hunger assessment(48 hours)
- Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)(48 hours)
- Global quality of life(48 hours)