Effect of IMN1207 Versus Casein on Weight Loss, Survival and Quality of Life in Non-small Cell Lung Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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NON-SMALL CELL LUNG CANCER

Intervention / Treatment
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* Dietary Supplement: IMN1207
* Dietary Supplement: Casein


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMN1207<br>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: IMN1207<br>* 20 grams of IMN1207 per day for 40 weeks.<br>|
| Placebo Comparator: Casein<br>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. | Dietary Supplement: Casein<br>* 20 grams of Casein per day for 40 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period |  | 66 weeks | 
| The change in hand grip force. |  | 40 weeks | 
| The change in Karnofsky performance status |  | 40 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 plasma concentration of C-reactive protein (CRP). |  | 40 weeks | 
| The change in lymphocyte counts. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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