EFFECT OF IMN1207 VERSUS CASEIN ON SURVIVAL, WEIGHT LOSS 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
The purpose of this study is to confirm the effect of a cysteine-rich non-heated whey protein formulationIMN1207 on the reversal of weight loss (cancer-related wasting) and to test the hypothesis that IMN1207administration (19.4 g protein daily) versus casein (19.4g protein daily) over a period of 40 weeks increasesthe survival of non-small cell lung cancer patients with or without conventional therapy, i.e., chemotherapyor radiation. In addition, this study is prospectively designed to determine the effect of IMN1207 on thequality of life in a defined subgroup of patients.
This trial is a multi-center, randomized double-blind study involving subjects with stage III or stage IVnon-small cell lung cancer. Fifty percent of subjects will receive the investigational study product IMN1207 and the remaining subjects will receive a placebo in the form of casein. Neither the subject nor theinvestigator will know into which group the subject has been placed. Subjects will be separatelyrandomized into two strata by an independent biostatistician based on their C-Reactive Protein (CRP)levels and white blood cell (WBC) counts:Stratum A: CRP <40 mg/L and WBC < 11x109/L (i.e. subjects with relatively low levels ofinflammation);Stratum B: CRP ³ 40 mg/L and/or WBC ³ 11x109/L (i.e. subjects with relatively high levels ofinflammation.Each stratum will be separately randomized into the two treatment arms. Note: At the end of the study thetwo strata will be analyzed separately as well as collectively.
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Canadian Cancer Society