Effect of IMN1207 Versus Casein on, Weight Loss, Survival and Quality of Life in Non-small Cell Lung Cancer Patients During or Following Chemotherapy, Radiation or Surgery: A Multi-center Randomized, Double-blind Study - Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 10
- 主要终点
- The primary endpoint of the study is the % change in body weight in the IMN1207 group compared to casein over a 40 weeks treatment period.
研究概览
简要总结
The primary aim of this IMN 1207 follow-up study is to confirm the effect of a cysteine-rich non-denatured whey protein isolate formulation IMN1207 (20g daily) versus casein (20 g daily) on the reversal of weight loss (cancer-related wasting) over a 40 week treatment period in non-small cell lung cancer patients with or without conventional therapy, i.e., chemotherapy or radiation. And to test the hypothesis that over a period of 66 weeks observation period which includes a 6 months follow-up period, increases the survival of these patients.
详细描述
This new IMN 1207 study is a follow-up study to the first IMN 1207 trial which was sponsored by Immunotec Inc during the last 3 years. The study revealed that the cysteine-rich whey protein isolate formulation IMN 1207 caused a significant reversal of weight loss (P <0.05) and a conspicuous increase in survival. The outcome of the first IMN 1207 study has been published in (Tozer RG, et al. Cysteine-Rich Protein Reverses Weight Loss in Lung Cancer Patients Receiving Chemotherapy or Radiotherapy. Antioxid Redox Signal. 2008 Feb; 10(2):395-402). PMID:18158761.
The purpose of this IMN 1207 follow-up study is to confirm the effect of a cysteine-rich non-denatured whey protein isolate formulation IMN1207 (20g daily) versus casein (20 g daily) on the reversal of weight loss (cancer-related wasting) over a 40 week treatment period in non-small cell lung cancer subjects with or without conventional therapy, i.e., chemotherapy or radiation. In addition, it is prospectively designed to test the hypothesis that, IMN1207 versus casein over a period of 66 weeks observation period which includes a 6 months follow-up period, increases the survival of these subjects. Also, the effect of IMN1207 on the quality of life in a defined subgroup of subjects will be determined.
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
- Triple (Participant, Care Provider, 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
- •Non small cell lung cancer stage III or stage IV.
- •Karnofsky performance status greater or equal to 70%.
- •Expected participation in study for more than 3 months.
- •Involuntary decrease in body weight of more than 3% over the 1-5 months period immediately preceding study entry.
- •Age 18 or older.
- •Serum creatine less or equal to 3.0mg/dL or 265 µmol/L.
- •Total bilirubin in the normal range (0.2-1.2 mg/dL) SGPT equal to or less than 4 times the upper limit of normal.
- •Reliable contraception (ovariectomy, hysterectomy, tubuligation for at least six months, oral contraceptive, barrier method, etc.) for women of child bearing potential.
排除标准
- •History of angioedema or allergic reactions to any compound employed in this study.
- •Pregnancy and lactating.
- •Uncontrolled metastatic brain tumors.
- •Milk protein intolerance.
- •Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements.
- •Presence of ascitis or edema according to principle investigator's clinical judgment.
- •Significant anemia, as defined by the requirement of treatment with EPO.
- •Subjects with either mild or soy allergy/intolerance.
结局指标
主要结局
The primary endpoint of the study is the % change in body weight in the IMN1207 group compared to casein over a 40 weeks treatment period.
时间窗: 40 weeks
次要结局
- The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period(66 weeks)
- The assessment of the McGill QOL and the modified Edmonton Symptom Assessment Scale (ESAS).(40 weeks)
- The 'repeated standing up/sitting down' test from the Simmonds Physical Performance assessment battery.(40 weeks)
- The change in the dose of chemotherapy (percent) or discontinuation of chemotherapy or interruption of radiation in response to patients' cachexia.(40 weeks)
- The change in hand grip force.(40 weeks)
- The change in lymphocyte counts.(40 weeks)
- The change in the plasma concentration of C-reactive protein (CRP).(40 weeks)
- The change in Karnofsky performance status(40 weeks)