search
Back to results

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

Primary Purpose

NON-SMALL CELL LUNG CANCER

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
IMN1207
Casein
Sponsored by
Immunotec Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NON-SMALL CELL LUNG CANCER focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • British Columbia Cancer Agency
  • Juravinski Cancer Centre
  • CHUM - Hopital Notre Dame
  • Jewish General Hospital
  • Allan Blair Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMN1207

Casein

Arm Description

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: 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.

Outcomes

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.

Secondary Outcome Measures

The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period
The change in hand grip force.
The change in Karnofsky performance status
The assessment of the McGill QOL and the modified Edmonton Symptom Assessment Scale (ESAS).
The 'repeated standing up/sitting down' test from the Simmonds Physical Performance assessment battery.
The change in the plasma concentration of C-reactive protein (CRP).
The change in lymphocyte counts.
The change in the dose of chemotherapy (percent) or discontinuation of chemotherapy or interruption of radiation in response to patients' cachexia.

Full Information

First Posted
January 8, 2010
Last Updated
January 16, 2015
Sponsor
Immunotec Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01046383
Brief Title
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

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
Slower than anticipated recruitment
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunotec Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMN1207
Arm Type
Experimental
Arm Description
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.
Arm Title
Casein
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
IMN1207
Intervention Description
20 grams of IMN1207 per day for 40 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Casein
Intervention Description
20 grams of Casein per day for 40 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period
Time Frame
66 weeks
Title
The change in hand grip force.
Time Frame
40 weeks
Title
The change in Karnofsky performance status
Time Frame
40 weeks
Title
The assessment of the McGill QOL and the modified Edmonton Symptom Assessment Scale (ESAS).
Time Frame
40 weeks
Title
The 'repeated standing up/sitting down' test from the Simmonds Physical Performance assessment battery.
Time Frame
40 weeks
Title
The change in the plasma concentration of C-reactive protein (CRP).
Time Frame
40 weeks
Title
The change in lymphocyte counts.
Time Frame
40 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L3
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
CHUM - Hopital Notre Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs