Anorexia, Cachexia, Carcinoma, Non-Small-Cell Lung, Weight Loss
Conditions
Brief summary
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.
Interventions
DRUGBetamarc
2 tabs BID
Sponsors
Anaborex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate | 25 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination | 25 weeks |
Countries
China, Taiwan
Outcome results
None listed