NON-SMALL CELL LUNG CANCER
Conditions
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
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.
Interventions
DIETARY_SUPPLEMENTIMN1207
20 grams of IMN1207 per day for 40 weeks.
DIETARY_SUPPLEMENTCasein
20 grams of Casein per day for 40 weeks
Sponsors
Immunotec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 40 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The change in hand grip force. | 40 weeks |
| The change in Karnofsky performance status | 40 weeks |
| The assessment of the McGill QOL and the modified Edmonton Symptom Assessment Scale (ESAS). | 40 weeks |
| The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period | 66 weeks |
| The change in the plasma concentration of C-reactive protein (CRP). | 40 weeks |
| The change in lymphocyte counts. | 40 weeks |
| The change in the dose of chemotherapy (percent) or discontinuation of chemotherapy or interruption of radiation in response to patients' cachexia. | 40 weeks |
| The 'repeated standing up/sitting down' test from the Simmonds Physical Performance assessment battery. | 40 weeks |
Countries
Canada
Outcome results
None listed