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Property:Results after intervention

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Overall: Number in % intervention arm: 19, control arm: 36; RR = 0.53 (95% CI 0.19 – 0.92); OR = 0.42 (95% CI: 0.19, 0.92); p = 0.04, sign. Recurrences in the first year: intervention arm: 66.7% of recurrences, control arm: 75% of recurrences Time to recurrence in months (mean (SD)): intervention arm: 9 (8.1), control arm: 8.33 (6.1); p = 0.9, not sign. Separated by smoking status: Smokers: intervention arm: 25%; control arm: 50%; p = 0.06 Non-smoker: intervention arm: 15.4%; control arm: 26.7%; p = 0.15  +
'''Overall''' No significant difference between intervention and control group for hazard ratio (p = 0.081) ''Multivariate analysis'' (controlled for age, lymphocyte percentage, absolute polymorphonuclear leukocyte count (PMN)) HR = 1.60 (95% CI: 1.05, 2.43); p = 0.014 (meaning mortality risk in control group 60% higher than in intervention group)  +
'''Overall''' Number of side effects ≥ grade 2 - intervention group: 13/56 - control group: 3/67 - p = 0.002  +
'''Overall''' No significant difference between intervention and control group for hazard ratio (p = 0.11) ''Multivariate analysis'' (controlled for age, lymphocyte percentage, absolute polymorphonuclear leukocyte count (PMN)) HR = 1.53 (95% CI: 1.01, 2.31); p = 0.022 (meaning risk of progression in control group 53% higher than in intervention group)  +
'''Overall''' No significant differences between arms regarding change since baseline (after 6 weeks p=0.399, after 3 months p=0.943); no difference in fatigue levels on the quality of life scales (no p-value reported)  +
'''Overall''' No significant differences in occurrence of nausea/vomiting (p=0.805), infections (p=0.144), diarrhea (p=0.945), constipation (p=0.572) and nephrotoxicity (p=0.516); less frequent occurrence of fatigue in intervention arm (p = 0.003)  +
Overall: * Hearing dysfunction n=1 each in the intervention arm and placebo arm; * elevated creatinine n=1 in the placebo arm; * myelosuppression: anemia in the placebo arm n=1; * leukopenia in the intervention arm n=3 and placebo arm n=2; * dermatitis in the intervention arm n=2; * dry mouth in the placebo arm n=2; * dysgeusia in the intervention arm n=2, placebo arm n=1; * odyno-/dysphagia in the intervention arm n=1, placebo arm n=2; * oral/throat pain in the placebo arm n=2; * mucus/sputum intervention arm n=3, placebo arm n=1  +
Mean (95% CI, 6 months after chemotherapy) Sensory Vitamin E: 1.72 (1.35, 2.10), Vitamin B12: 1.60 (1.09, 2.11), Carnitine: 0.65 (0.30, 1.00), Glutamine: 0.58 (0.21, 0.95) F-Wert (ANOVA, including values from after 3 chemotherapy cycles and after 6 chemotherapy cycles) = 1.824; p = 0.115, ns. Post-Hoc Analysis: Vitamin E vs. Vitamin B12: p = 0.446 Vitamin E vs. Carnitine: p < 0.001, sign. Vitamin E vs. Glutamine: p = 0.002, sign. No difference between Vit. E and Vit. B12, but Vit. E better progression than glutamine and ALC Motor Vitamin E: 1.39 (1.09, 1.69), Vitamin B12: 1.40 (1.08, 1.72), Carnitine: 0.20 (0.01, 0.39), Glutamine: 0.32 (0.09, 0.55), F(ANOVA, including values from after 3 chemotherapy cycles and after 6 chemotherapy cycles) = 2.267; p = 0.045, sign. Post-Hoc Analysis: Vitamin E vs. Vitamin B12: p = 0.227, ns. Vitamin E vs. Carnitine: p < 0.001, sign. Vitamin E vs. Glutamine: p < 0.001, sign. No difference between Vit. E and Vit. B12, but Vit. E better progression than glutamine and ALC Pain Vitamin E: 1.33 (0.95, 1.71), Vitamin B12: 1.30 (0.99, 1.61), Carnitine: 0.10 (-0.04, 0.24), Glutamine: 0.26 (0.05, 0.48), F (ANOVA, including values from after 3 chemotherapy cycles and after 6 chemotherapy cycles)= 3.358; p = 0.004, sign. Post-Hoc-Analysis: Vitamin E vs. Vitamin B12: ns.; p = NI Vitamin E vs. Carnitine: p < 0.001, sign. Vitamin E vs. Glutamine: p < 0.001, sign. No difference between Vit. E and Vit. B12, but Vit. E better progression than glutamine and ALC  +
2 weeks after end of the treatment, difference between results of intervention and placebo arm were statistically significant (p < 0.05)  +
Median follow-up of 51 months (range 6-75): 5-year overall survival in the intervention arm was 91.9% vs. 83.1% in the control arm, no significant difference; p = 0.34  +
Median follow-up of 49 months (range, 0-75): 5-year disease free survival in the intervention arm was 80.1% vs. 83.2% in the control arm, no significant difference; p = 0.74  +