Effect of IMN1207 Versus Casein on Weight Loss, Survival and Quality of Life in Non-small Cell Lung Cancer Patients
NON-SMALL CELL LUNG CANCER
About this trial
This is an interventional treatment trial for NON-SMALL CELL LUNG CANCER focused on measuring 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
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.
Sites / Locations
- British Columbia Cancer Agency
- Juravinski Cancer Centre
- CHUM - Hopital Notre Dame
- Jewish General Hospital
- Allan Blair Cancer Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
IMN1207
Casein
Dietary Supplement: IMN1207 Stratum A: CRP <40 mg/L and WBC < 11x109/L (i.e. subjects with relatively low levels of inflammation). Stratum B: CRP ≥ 40 mg/L and/or WBC ≥ 11x109/L (i.e. subjects with relatively high levels of inflammation.
Dietary Supplement: Casein. Stratum A: CRP <40 mg/L and WBC < 11x109/L (i.e. subjects with relatively low levels of inflammation). Stratum B: CRP ≥ 40 mg/L and/or WBC ≥ 11x109/L (i.e. subjects with relatively high levels of inflammation.