Clinical trial NCT01046383: Effect of IMN1207 Versus Casein on Weight Loss, Survival and Quality of Life in Non-small Cell Lung Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: NON-SMALL CELL LUNG CANCER
Keywords: 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
Lead sponsor: Immunotec Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 40 weeks
Secondary outcomes:
measure: The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period
timeFrame: 66 weeks
measure: The change in hand grip force.
timeFrame: 40 weeks
measure: The change in Karnofsky performance status
timeFrame: 40 weeks
measure: The assessment of the McGill QOL and the modified Edmonton Symptom Assessment Scale (ESAS).
timeFrame: 40 weeks
measure: The 'repeated standing up/sitting down' test from the Simmonds Physical Performance assessment battery.
timeFrame: 40 weeks
measure: The change in the plasma concentration of C-reactive protein (CRP).
timeFrame: 40 weeks
measure: The change in lymphocyte counts.
timeFrame: 40 weeks
measure: The change in the dose of chemotherapy (percent) or discontinuation of chemotherapy or interruption of radiation in response to patients' cachexia.
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Hopital Notre Dame
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
Study officials:
References: