Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slower than anticipated recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NON-SMALL CELL LUNG CANCER | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Casein | Dietary Supplement | — | UNRESOLVED |
| IMN1207 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IMN1207
- 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.
- interventionNames
- Dietary Supplement: IMN1207
- type
- PLACEBO_COMPARATOR
- label
- Casein
- 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.
- interventionNames
- Dietary Supplement: Casein
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available