Oral Nutritional Supplementation in Cancer Patients Who Were Receiving Chemo/Chemoradiation Therapy: A Multicenter, Randomized Phase II Study.

Oral nutritional supplementation (ONS) in cancer patients is justified by the low food intake caused by several factors. However, ONS can be affected by adverse events (AEs) correlated to treatment. This study aimed to compare the safety and efficacy of ONS (whey protein isolated, leucin, zinc-IMMAX®) during oncologic treatment. Patients in chemo/chemoradiotherapy were randomly assigned to receive IMMAX®+nutritional counseling (NC) according to daily requirements (S arm) or NC alone (C arm) for 4 weeks. Body weight (BW), %fat-free mass (%FFM) and nutrition intake were assessed before and after. In S arm, calories from IMMAX met the energy requirements. AEs were classified according to CTC-AE-NCI. Eighty-five patients were included (51 females). After 4 weeks, the median of caloric intake, BW and %FFM were not statistically different in C arm. In S arm, median ONS intake was 81 g/332 kcal/day, protein intake was higher (pre: 66.75 ± 31.57 g; post: 88.57 ± 35.11 g;  < 0.01) and calories as well (pre: 1,549 ± 596 kcal; post: 1,756 ± 614 kcal;  = 0.02). The most common treatment related AEs were anemia, nausea/vomiting, not different between the arms. AEs supplement related were constipation and diarrhea (2 patients/4.6% each). IMMAX was safe, well tolerated, it did not interfere with oncologic treatment and provided significant amount of protein intake in this patient population, with few related AEs.