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

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 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.

Study Overview

• Status: Terminated
• Conditions: NON-SMALL CELL LUNG CANCER
• Intervention / Treatment: Dietary supplement: IMN1207; Dietary supplement: Casein

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L3
      • British Columbia Cancer Agency
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H2L 4M1
      • CHUM - Hopital Notre Dame
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Immunotec Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (ESTIMATE): January 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 16, 2015
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: QUALITY OF LIFE; RADIOTHERAPY; SURGERY; CHEMOTHERAPY; SURVIVAL; NON-SMALL CELL LUNG CANCER PATIENTS; WEIGHT LOSS; CYSTEINE-RICH WHEY PROTEIN ISOLATE; IMN1207; CANCER-RELATED WASTING (CACHEXIA); BODY WEIGHT; NUTRITIONAL PROTEIN SUPPLEMENT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Body Weight; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Body Weight Changes; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Weight Loss; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: IMN1207-07