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

Phase 3

Terminated

• Conditions: NON-SMALL CELL LUNG CANCER
• Interventions: Dietary Supplement: Casein; Dietary Supplement: IMN1207

• Registration Number: NCT01046383
• Lead Sponsor: Immunotec Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-12
• Study Start: 2010-06
• Status Verified: 2011-06
• Primary Completion: 2012-06
• Study Completion: 2013-06
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Casein	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.
IMN1207	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period	66 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 dose of chemotherapy (percent) or discontinuation of chemotherapy or interruption of radiation in response to patients' cachexia.	40 weeks
The change in hand grip force.	40 weeks
The change in lymphocyte counts.	40 weeks
The change in Karnofsky performance status	40 weeks
The change in the plasma concentration of C-reactive protein (CRP).	40 weeks

Trial Locations

Locations (5)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

CHUM - Hopital Notre Dame; 🇨🇦 Montreal, Quebec, Canada

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

Allan Blair Cancer Centre; 🇨🇦 Regina, Saskatchewan, Canada

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada