Table 1.
Baseline Clinicopathological Characteristics of Enrolled Patients (N = 47).
| A: ProLYOtin (N = 22) | B: Placebo (N = 25) | |
|---|---|---|
| Sex, n (%) | ||
| Male | 15 (68.2) | 14 (56.0) |
| Female | 7 (31.8) | 11 (44.0) |
| Median age, years | 68 (34-83) | 67 (49-85) |
| Comorbidity, n (%) | ||
| CV | 7 (31.8) | 10 (40.0) |
| EM | 2 (9.1) | 5 (20.0) |
| CV + EM | 6 (27.3) | 3 (12.0) |
| Tumor site, n (%) | ||
| Right colon | 10 (45.5) | 9 (36.0) |
| Left colon | 6 (27.3) | 14 (56.0) |
| Rectum | 6 (27.3) | 2 (8.0) |
| Stage of disease, n (%) | ||
| II | 6 (27.3) | 8 (32.0) |
| III | 7 (31.8) | 10 (40.0) |
| IV | 9 (40.9) | 7 (28.0) |
| Chemotherapy regimen | ||
| Capecitabine | 6 (27.3) | 6 (24.0) |
| FOLFOX +/− biologic agent | 13 (59.1) | 15 (60.0) |
| XELOX | 3 (13.6) | 4 (16.0) |
| PS, ECOG, n (%) | ||
| 0 | 18 (81.8) | 24 (96.0) |
| 1 | 4 (18.2) | 1 (4.0) |
| EORTC QLQC-30, median (range) % | ||
| Quality of life scale | 66 (33-100) | 66 (0-100) |
| Function scale | 82 (36-100) | 81 (58-100) |
| Symptoms scale | 18 (0-38) | 18 (3-90) |
| MNA, n (%) | ||
| 24-30 (normal) | 7 (31.8) | 12 (48.0) |
| 17-23.5 (at risk of malnutrition) | 11 (50.0) | 9 (36,0) |
| <17 (malnourished) | 4 (18.2) | 4 (16.0) |
| MUST, n (%) | ||
| 0 | 5 (22.7) | 14 (56.0) |
| 1 | 7 (31.8) | 8 (32.0) |
| ≥2 | 10 (45.5) | 3 (12.0) |
| Body mass index, n (%) | ||
| 18.5-24.9 kg/m2 | 12 (54.5) | 13 (52.0) |
| 25-30 kg/m2 | 7 (31.8) | 7 (28.0) |
| 30.1-40 kg/m2 | 3 (13.6) | 5 (20.0) |
| <18.5 kg/m2 | 0 | 0 |
Abbreviations: CV, cardiovascular; EM, endocrine-metabolic; PS, performance status; ECOG, European Cooperative Oncology Group; EORTC, European Organization for the Research and Treatment of Cancer; MNA, Mini Nutritional Assessment; MUST, Malnutrition Universal Screening Tool.