A Phase 3 interventional study of IMN1207 and Casein in NON-SMALL CELL LUNG CANCER, sponsored by Immunotec Inc.. Terminated at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-21.
Sponsored by Immunotec Inc. · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
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
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 IMN1207 per day for 40 weeks.
20 grams of Casein per day for 40 weeks
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
The survival/mortality over a 66 weeks observation period which includes a 6 months follow-up period
Time frame: 66 weeks
The change in hand grip force.
Time frame: 40 weeks
The change in Karnofsky performance status
Time frame: 40 weeks
The assessment of the McGill QOL and the modified Edmonton Symptom Assessment Scale (ESAS).
Time frame: 40 weeks
The 'repeated standing up/sitting down' test from the Simmonds Physical Performance assessment battery.
Time frame: 40 weeks
The change in the plasma concentration of C-reactive protein (CRP).
Time frame: 40 weeks
The change in lymphocyte counts.
Time frame: 40 weeks
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
This study is terminated, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Immunotec Inc.