2.5. Statistics and Data Analysis
cancer type, cancer
CANCER
Sample size calculation was based on estimates from previous studies on the effect of nutritional intervention on protein intake in cancer patients with an expected mean difference in protein intake of 16 g in the IG vs. the CG (standard deviation (SD) of difference: 24 g). Based on these estimates and using a significance level (α) of 0.05, power of 80% and a 2:1 randomisation, a sample size of 84 subjects (56 IG and 28 CG) was calculated based on a two-sample All analyses were performed with the modified Intention-To-Treat (mITT) subject data set, i.e., subjects who had completed the first treatment cycle (primary endpoint for protein intake). Descriptive statistics were reported as mean (SD) and/or median (interquartile range (IQR)) for skewed distributed data, or as Inferential statistics were only performed for the primary outcome parameter using an Analysis of Covariance (ANCOVA) model with T1 values as outcome and T0 values and the group as covariates, and adjusting for cancer type and cancer treatment as stratification factors. The normality assumption was checked and satisfied for ANCOVA analysis, so the model provided a good fit despite the small sample size. Furthermore, t-tests and the Wilcoxon rank-sum test were performed, and only the All analyses were performed with SAS version 9.4 (SAS Institute Inc., Cary, NC, USA) [