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

January 8, 2010
January 29, 2013
June 2010
June 2012   (final data collection date for primary 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. [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01046383 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of IMN1207 Versus Casein on Weight Loss, Survival and Quality of Life in Non-small Cell Lung Cancer Patients
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
NON-SMALL CELL LUNG CANCER
  • Dietary Supplement: IMN1207
    20 grams of IMN1207 per day for 40 weeks.
  • Dietary Supplement: Casein
    20 grams of Casein per day for 40 weeks
  • 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.

    Intervention: Dietary Supplement: IMN1207
  • 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.

    Intervention: Dietary Supplement: Casein
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
June 2013
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01046383
IMN1207-07
No
Immunotec Inc.
Immunotec Inc.
Not Provided
Not Provided
Immunotec Inc.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP