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

This study has been terminated.
(Slower than anticipated recruitment)
Sponsor:
Information provided by (Responsible Party):
Immunotec Inc.
ClinicalTrials.gov Identifier:
NCT01046383
First received: January 8, 2010
Last updated: January 29, 2013
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Immunotec Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046383

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
Sponsors and Collaborators
Immunotec Inc.
  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 April 15, 2014