A Pilot Open Label Randomized Controlled Study to Evaluate the Dose Tolerance Safety and Efficacy of VT-122 Regimen for the Treatment of Cachexia in Subjects With Stage IV Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 8
- 主要终点
- Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
研究概览
简要总结
Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized.
To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. Consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of VT-122 in subjects with NSCLC who have hypercatabolic cachexia.
详细描述
The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen
This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 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
- •Subjects with NSCLC
- •Demonstrating average weight loss of 5% within 2 months prior to enrollment
- •Heart rate of 72 bpm or greater
- •Negative pregnancy test (female patients of child bearing age)
- •Able to give informed consent
- •Able to be administered medication
- •Able to take food and defined nutritional support
- •Have not been on beta-blockers for a minimum of 1 week prior to administration of the medication screening dose
- •Have not undergone surgery for at least 2 weeks prior to entry into trial
- •Have not been on chemotherapy, immunotherapy, biologic therapy, radio therapy, and experimental therapy for a minimum of two weeks prior to medication screening dose and during their participation in this trial
- •An expected survival for a minimum of 12 weeks
排除标准
- •Contraindication to nonsteroidal antiinflammatory drugs (NSAIDs) and beta blockers
- •Blood pressure less than 100/65
- •Weight loss of 15% within 2 months prior to recruitment
- •Hypersensitivity reaction to the active components in VT-122
- •History of myocardial infraction within the past 3 months
- •Congestive heart failure (as determined by symptoms and ECG)
- •A-V block of second or third degree
- •Unstable angina
- •Uncontrolled diabetes
- •Unable to be assessed for grip strength
- •A positive pregnancy test
- •Chronic infection or sepsis
- •History of bleeding disorders
- •Patients with peripheral edema
- •Patients on digoxin or other chronotropic drugs
- •Patients with evidence of severe dehydration
- •Patients with evidence of ascites
研究组 & 干预措施
Group B, Low Dose VT-122
VT-122 (dose of etodolac: 400 mg/day) + supportive care
干预措施: VT-122 low dose (Drug)
Group C, High Dose VT-122
VT-122 (dose of etodolac: 800 mg/day) + supportive care
干预措施: VT-122 high dose (Drug)
结局指标
主要结局
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
时间窗: 4 weeks
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
时间窗: 4 weeks
次要结局
未报告次要终点