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
18 Years
N/A
Both
NON-SMALL CELL LUNG CANCER
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
40 weeks
Safety Issue:
No
Authority:
Canada: Health Canada
Study ID:
IMN1207-07
NCT ID:
NCT01046383
Start Date:
June 2010
Completion Date:
June 2013
Related Keywords:
- Non-Small Cell Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Weight Loss
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