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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


Phase 3
18 Years
N/A
Not Enrolling
Both
NON-SMALL CELL LUNG CANCER

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Trial Information

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


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.


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 ┬Ámol/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.

Type of Study:

Interventional

Study Design:

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

Outcome 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.

Outcome Time Frame:

40 weeks

Safety Issue:

No

Authority:

Canada: Health Canada

Study ID:

IMN1207-07

NCT ID:

NCT01046383

Start Date:

June 2010

Completion Date:

June 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Weight Loss

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