2.4. Outcome Measures
Cancer, cancer, taste and smell perception
ADVERSE EVENT, CANCER, ADVERSE EVENT, SECONDARY, CANCER
As subjects had anti-cancer treatment regimens with treatment cycles of varying length (2, 3 or 6 weeks); assessment timepoints differed accordingly. Assessments at timepoint 0 (T0) were related to the start of the study (baseline); assessments at timepoint 1 (T1) were related to the planned end of the first treatment cycle, i.e., assessments took place at the end of week 2, 3 or 6 according to the planned duration of a treatment cycle; assessments at timepoint 2 (T2) were related to the planned end of treatment cycle 2 in case of treatment schedules with 3-week treatment cycles or to the planned end of treatment cycle 3 in case of treatment schedules with 2-week cycles. Assessments at timepoint 3 (T3) occurred at the end of the 12-week intervention period for all subjects. A treatment cycle was defined as the interval between the start of administration of each treatment sequence and the next.The primary outcome measure was defined as the average protein intake per day (g/day; g/kg BW/day) corrected for baseline (T0) after one cycle of first-line anti-cancer treatment assessed with a three-day food diary completed at T0 and at T1. The secondary outcome measures included the proportion of subjects with a protein intake ≥1.0 g/kg BW/day, which represents the lower limit of the ESPEN recommendations for protein intake for cancer patients, at T1 and also a change in body weight during the 12-week study period.Food diaries were completed by subjects at home and validated by study staff at the next hospital visit. Analysis of food diaries was undertaken by a local dietitian using country-specific nutritional analysis software. Compliance was monitored in the IG using a diary where the subject documented the amount of study product consumed (0–¼–½–¾–1) per serving. Any reasons for non-compliance were also recorded. Body weight was measured using a calibrated weighing scale at all timepoints (T0-3).Other exploratory outcome measures were included: average protein intake per day (g/day; g/kg BW/day) corrected for baseline at T2 and T3, total dietary energy intake (kcal/kg BW/day) and the proportion of subjects with a protein intake ≥1.0 g/kg BW/day at T0 and at T2 and T3. Factors impacting dietary intake were also included as exploratory outcome measures: symptoms that impacted dietary intake and alteration in taste and smell perception questionnaire. Health-related quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [Adverse events (AEs) were recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 system [