Prospective study on the efficacy and safety of anamorelin for cachexia and identification of predictors of efficacy
Not Applicable
Recruiting
- Conditions
- non small cell lung cancer
- Registration Number
- JPRN-UMIN000045059
- Lead Sponsor
- Department of Respiratory Medicine, Japanese Red Cross Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who have previously been treated with anamorelin 2) Patients who are contraindicated for administration according to the package insert 3) Other patients who are judged to be inappropriate as a target by the judgment of a doctor
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients who maintained or increased lean body mass by the 4-Compartment model (4C) method 8 weeks after anamorelin administration
- Secondary Outcome Measures
Name Time Method 1. Change in lean body mass from baseline at each time of evaluation 2. Amount of change from baseline in total weight at each evaluation period 3. 3. Amount of change in grip strength from baseline at each evaluation period 4. Amount of change in skeletal muscle mass index (SMI) at each evaluation period 5. FAACT score Average change over 8 weeks from each baseline 6. Average change from baseline in total FAACT score for 8 weeks 7. 8-week average change from baseline in serum protein (TP) and albumin (Alb) 8. Changes in ECOG performance status (PS) 9. Factors that predict the primary and secondary endpoints 10. Incidence of Grade 1 or higher adverse events during treatment If continuous treatment with the drug is continued after 11.8 weeks, the adverse events, lean body mass, FAACT score, anamorelin oral administration period, and survival period should be reduced as much as possible from the start of the drug treatment to 1 year later.