non small cell lung cancer
Conditions
Interventions
None listed
Sponsors
Department of Respiratory Medicine, Japanese Red Cross Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cancer cachexia patients associated with non-small cell lung cancer 2) Stage III or stage III / IV or postoperative recurrence non-small cell lung cancer for which chemoradiotherapy is indicated 3) Allow 5% or more non-arbitrary weight loss within the last 6 months 4) Meet the following criteria for cancer cachexia Anorexia Satisfy 2 or more of the following 4 items a) Fatigue or malaise, b) Generalized muscle weakness, c) Brachial muscle circumference (cm) <10th percentile (less than the bottom 10% of the distribution of brachial muscle circumference), d) Satisfy at least one of the following three items [1. C reactive protein (CRP) value greater than 0.5 mg / dL, 2. hemoglobin (Hb) value less than 12 g / dL, 3. albumin value less than 3.2 g / dL] 5) Patients who have written consent to participate in this study 6) Patients over 20 years old
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who maintained or increased lean body mass by the 4-Compartment model (4C) method 8 weeks after anamorelin administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactTakehiro Izumo
Japanese Red Cross Medical Center Department of Respiratory Medicine
Outcome results
None listed