effect of imn1207 versus casein on weight loss, survival and quality of life in non-small cell lung cancer patients

Conditions: NON-SMALL CELL LUNG CANCER

Summary: 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.

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.

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.

Keywords: non-small cell lung cancer patients weight loss quality of life survival chemotherapy radiotherapy surgery cysteine-rich whey protein isolate imn1207 cancer-related wasting (cachexia) body weight nutritional protein supplement