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

NON-SMALL CELL LUNG CANCER Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01046383
• Other study ID #: IMN1207-07
• Status: Terminated
• Phase: Phase 3
• First received: January 8, 2010
• Last updated: January 16, 2015
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2011
• Source: Immunotec Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• NON-SMALL CELL LUNG CANCER
• Weight Loss

Intervention

Dietary Supplement:
• IMN1207
20 grams of IMN1207 per day for 40 weeks.
• Casein
20 grams of Casein per day for 40 weeks

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	CHUM - Hopital Notre Dame	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	British Columbia Cancer Agency	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Immunotec Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period		66 weeks	No
Secondary	The change in hand grip force.		40 weeks	No
Secondary	The change in Karnofsky performance status		40 weeks	No
Secondary	The assessment of the McGill QOL and the modified Edmonton Symptom Assessment Scale (ESAS).		40 weeks	No
Secondary	The 'repeated standing up/sitting down' test from the Simmonds Physical Performance assessment battery.		40 weeks	No
Secondary	The change in the plasma concentration of C-reactive protein (CRP).		40 weeks	No
Secondary	The change in lymphocyte counts.		40 weeks	No
Secondary	The change in the dose of chemotherapy (percent) or discontinuation of chemotherapy or interruption of radiation in response to patients' cachexia.		40 weeks	No