Effect of IMN1207 Versus Casein on Weight Loss, Survival and Quality of Life in Non-small Cell Lung Cancer Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
NON-SMALL CELL LUNG CANCER |
Dietary Supplement: IMN1207 Dietary Supplement: Casein |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
- 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. [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
- The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period [ Time Frame: 66 weeks ] [ Designated as safety issue: No ]
- The change in hand grip force. [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
- The change in Karnofsky performance status [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
- The assessment of the McGill QOL and the modified Edmonton Symptom Assessment Scale (ESAS). [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
- The 'repeated standing up/sitting down' test from the Simmonds Physical Performance assessment battery. [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
- The change in the plasma concentration of C-reactive protein (CRP). [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
- The change in lymphocyte counts. [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
- The change in the dose of chemotherapy (percent) or discontinuation of chemotherapy or interruption of radiation in response to patients' cachexia. [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IMN1207
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
20 grams of IMN1207 per day for 40 weeks.
|
|
Placebo Comparator: Casein
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
20 grams of Casein per day for 40 weeks
|
Detailed Description:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 1L3 | |
| Canada, Ontario | |
| Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Canada, Quebec | |
| Jewish General Hospital | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| CHUM - Hopital Notre Dame | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
More Information
No publications provided
| Responsible Party: | Immunotec Inc. |
| ClinicalTrials.gov Identifier: | NCT01046383 History of Changes |
| Other Study ID Numbers: | IMN1207-07 |
| Study First Received: | January 8, 2010 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Immunotec Inc.:
|
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 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Weight Loss Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Body Weight Changes Body Weight Signs and Symptoms Caseins Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013