Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Betamarc is effective in improving the appetite and reversing weight loss in patients with advanced Non-Small Cell Lung Cancer.

Official Title
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A Randomized, Double-Blind, Pilot Study Comparing the Safety and Efficacy of Betamarc Plus Chemotherapy to Chemotherapy Alone in the Prevention and Treatment of CACS in Patients With Advanced NSCLC

Conditions
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Anorexia, Cachexia, Weight Loss, Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Betamarc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed Stage IIIB or IV non-resectable NSCLC. Recurrent disease after resection for earlier stage disease is acceptable as long as patients are at least 6 months from surgery. Treatment plan includes a platinum-based doublet chemotherapy. ECOG 0, 1 or 2. Self-reported loss of body weight or anorexia. Serum C-reactive protein ≥5 mg/L. Life expectancy of at least 6 months. Adequate bone marrow, liver and renal function. Normal serum potassium. Ability to comply with the study requirements and give written informed consent. Exclusion Criteria: Known physical or functional obstruction of the gastrointestinal tract, malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving tube feeding or parenteral nutrition, or unable to swallow investigational drug product. Concomitant therapy with an appetite stimulant. History of poorly controlled hypertension or congestive heart failure. Any implanted devices that could interfere with DXA scanning. Prolongation of QT interval. History of additional risk factors for torsades de pointe. Concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or ergot derivatives. Females who are breast feeding, pregnant or of child-bearing potential who are not using adequate birth control. Any second malignancy which might confound the interpretation of safety or efficacy assessments. Any condition which increases the patient's risk for participating in the study.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Betamarc|2 tabs BID|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate |  | 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination |  | 25 weeks |