Table 5.
EORTC QLQ-C30 scores on day 21, day 48 and day 84
| Indicators | Placebo (day 21) | SAOLP (day 21) | Statistic(t) (day 21) | P value (day 21) | Placebo (day 42) | SAOLP (day 42) | Statistic(t) (day 42) | P value (day 42) | Placebo (day 84) | SAOLP (day 84) | Statistic(t) (day84) | P value (day 84) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PF (physical function) | N (Nmiss) | 17 (1) | 17 (1) | 1.21 | 0.235 | 17 (1) | 15 (3) | 6.95 | <0.001 | 17 (1) | 15 (3) | 7.75 | <0.001 |
| Mean (SE) | 78.4(2.0) | 74.9(2.1) | 83.1(2.1) | 58.7(2.9) | 84.7(1.9) | 57.3(3.1) | |||||||
| RF (role function) | N (Nmiss) | 17 (1) | 17 (1) | 1.6 | 0.119 | 17 (1) | 15 (3) | 4.12 | <0.001 | 17 (1) | 15 (3) | 8.36 | <0.001 |
| Mean (SE) | 82.4 (5.0) | 71.6 (4.5) | 87.3 (4.2) | 58.9 (5.6) | 90.2 (3.5) | 48.9 (7.0) | |||||||
| EF (emotional functioning) | N (Nmiss) | 17 (1) | 17 (1) | 0.93 | 0.362 | 17 (1) | 15 (3) | 6.47 | <0.001 | 17 (1) | 15 (3) | 6.76 | <0.001 |
| Mean (SE) | 82.4 (4.1) | 76.5 (4.9) | 93.6 (2.4) | 60.6 (4.7) | 94.6 (2.1) | 60.0 (4.9) | |||||||
| CF (cognitive function) | N (Nmiss) | 17 (1) | 17 (1) | 1.94 | 0.061 | 17 (1) | 15 (3) | 2.94 | 0.006 | 17 (1) | 15 (3) | 6.19 | <0.001 |
| Mean (SE) | 83.3 (3.2) | 74.5 (3.2) | 92.2 (3.2) | 76.7 (4.2) | 92.2 (2.9) | 63.3 (3.7) | |||||||
| SF (social function) | N (Nmiss) | 17(1) | 17 (1) | 1.71 | 0.096 | 17 (1) | 15 (3) | 5.6 | <0.001 | 17 (1) | 15 (3) | 6.42 | <0.001 |
| Mean (SE) | 68.6 (4.7) | 58.8 (3.2) | 79.4 (3.7) | 46.7 (4.7) | 80.4 (3.6) | 40.0 (5.3) | |||||||
| QL (quality) | N (Nmiss) | 17 (1) | 17 (1) | 2.56 | 0.015 | 17 (1) | 15 (3) | 10.53 | <0.001 | 17 (1) | 15 (3) | 13.59 | <0.001 |
| Mean (SE) | 60.8 (2.7) | 50.0 (3.2) | 78.9 (2.4) | 37.2 (3.2) | 81.4 (1.5) | 32.8 (3.4) | |||||||
| FA (fatigue) | N (Nmiss) | 17 (1) | 17 (1) | −1.21 | 0.233 | 17 (1) | 15 (3) | −6.72 | <0.001 | 17 (1) | 15 (3) | −8.52 | <0.001 |
| Mean (SE) | 26.1 (3.9) | 32.0 (2.8) | 13.1 (3.0) | 51.1 (4.9) | 9.8 (2.3) | 62.2 (6.0) | |||||||
| NV (nausea and vomiting) | N (Nmiss) | 17 (1) | 17 (1) | −1.37 | 0.18 | 17 (1) | 15 (3) | −1.92 | 0.0 64 | 17 (1) | 15 (3) | −2.47 | 0.019 |
| Mean (SE) | 6.9 (2.9) | 13.7 (4.1) | 4.9 (2.8) | 15.6 (5.0) | 4.9 (2.4) | 16.7 (4.3) | |||||||
| PA (pain) | N (Nmiss) | 17 (1) | 17 (1) | −0.32 | 0.754 | 17 (1) | 15 (3) | −2.3 | 0.029 | 17 (1) | 15 (3) | −3.39 | 0.002 |
| Mean(SE) | 21.6(4.7) | 23.5(4.1) | 14.7(3.7) | 30.0(5.7) | 11.8(4.0) | 34.4(5.5) | |||||||
| DY (dyspnea) | N (Nmiss) | 17 (1) | 17 (1) | −0.68 | 0.28 | 17 (1) | 15 (3) | −2.67 | 0.012 | 17 (1) | 15 (3) | −3.68 | 0.001 |
| Mean (SE) | 17.6 (4.2) | 21.6 (4.0) | 9.8 (3.8) | 24.4 (3.9) | 5.9 (4.3) | 26.7 (3.6) | |||||||
| AP (appetite loss) | N (Nmiss) | 17 (1) | 17 (1) | −0.65 | 0.518 | 17 (1) | 15 (3) | −2.91 | 0.007 | 17 (1) | 15 (3) | −2.23 | 0.033 |
| Mean (SE) | 25.5 (4.5) | 29.4 (3.9) | 13.7 (4.1) | 28.9 (3.0) | 19.6 (4.1) | 33.3 (4.6) | |||||||
| CO (constipation) | N (Nmiss) | 17 (1) | 17 (1) | 0.34 | 0.734 | 17 (1) | 15 (3) | −1.4 | 0.171 | 17 (1) | 15 (3) | −2.3 | 0.029 |
| Mean (SE) | 13.7 (4.1) | 17.8 (4.0) | 5.9 (3.2) | 13.3 (4.4) | 3.9 (2.7) | 15.6 (4.4) | |||||||
| DI (diarrhea) | N (Nmiss) | 17 (1) | 17 (1) | −0.79 | 0.434 | 17 (1) | 15 (3) | −2.05 | 0.049 | 17 (1) | 15 (3) | −2.61 | 0.014 |
| Mean (SE) | 5.9 (3.2) | 9.8 (3.8) | 2.0 (2.0) | 11.1 (4.2) | 0 (0) | 13.3 (5.4) | |||||||
| FI (financial difficulties) | N (Nmiss) | 17 (1) | 17 (1) | 0.3 | 0.765 | 17 (1) | 15 (3) | −2.06 | 0.048 | 17 (1) | 15 (3) | −4.67 | <0.001 |
| Mean (SE) | 49.0 (4.2) | 47.1 (5.0) | 41.2 (3.5) | 57.8 (7.6) | 35.3 (4.5) | 71.1 (6.4) |