Regimen for the Treatment of Cachexia in Subjects With NSCLC

Study Overview
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Brief Summary
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Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized. To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. Consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of VT-122 in subjects with NSCLC who have hypercatabolic cachexia.

Detailed Description
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The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.

Official Title
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A Pilot Open Label Randomized Controlled Study to Evaluate the Dose Tolerance Safety and Efficacy of VT-122 Regimen for the Treatment of Cachexia in Subjects With Stage IV Non-Small Cell Lung Cancer

Conditions
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Cachexia

Intervention / Treatment
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* Drug: VT-122 low dose
* Drug: VT-122 high dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with NSCLC Demonstrating average weight loss of 5% within 2 months prior to enrollment Heart rate of 72 bpm or greater Negative pregnancy test (female patients of child bearing age) Able to give informed consent Able to be administered medication Able to take food and defined nutritional support Have not been on beta-blockers for a minimum of 1 week prior to administration of the medication screening dose Have not undergone surgery for at least 2 weeks prior to entry into trial Have not been on chemotherapy, immunotherapy, biologic therapy, radio therapy, and experimental therapy for a minimum of two weeks prior to medication screening dose and during their participation in this trial An expected survival for a minimum of 12 weeks Exclusion Criteria: Contraindication to nonsteroidal antiinflammatory drugs (NSAIDs) and beta blockers Blood pressure less than 100/65 Weight loss of 15% within 2 months prior to recruitment Hypersensitivity reaction to the active components in VT-122 History of myocardial infraction within the past 3 months Congestive heart failure (as determined by symptoms and ECG) A-V block of second or third degree Unstable angina Uncontrolled diabetes Unable to be assessed for grip strength A positive pregnancy test Chronic infection or sepsis History of bleeding disorders Patients with peripheral edema Patients on digoxin or other chronotropic drugs Patients with evidence of severe dehydration Patients with evidence of ascites

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A, control group<br>Supportive care only | |
| Active Comparator: Group B, Low Dose VT-122<br>VT-122 (dose of etodolac: 400 mg/day) + supportive care | Drug: VT-122 low dose<br>* VT-122 low dose, dose escalated<br>|
| Active Comparator: Group C, High Dose VT-122<br>VT-122 (dose of etodolac: 800 mg/day) + supportive care | Drug: VT-122 high dose<br>* VT-122 high dose, dose escalated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass |  | 4 weeks | 
| Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, anorexia, cachexia, grip strength, lean body mass