PMID- 32363940 OWN - NLM STAT- MEDLINE DCOM- 20210818 LR - 20210818 IS - 1532-7914 (Electronic) IS - 0163-5581 (Linking) VI - 73 IP - 3 DP - 2021 TI - Oral Nutritional Supplementation in Cancer Patients Who Were Receiving Chemo/Chemoradiation Therapy: A Multicenter, Randomized Phase II Study. PG - 442-449 LID - 10.1080/01635581.2020.1758170 [doi] AB - Introduction: 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(R)) during oncologic treatment.Methods: Patients in chemo/chemoradiotherapy were randomly assigned to receive IMMAX(R)+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.Results: 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; p < 0.01) and calories as well (pre: 1,549 +/- 596 kcal; post: 1,756 +/- 614 kcal; p = 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).Conclusion: 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. FAU - Faccio, Adilson Aparecido AU - Faccio AA AD - Department of Oncology, IRPCC - Instituto Ribeiraopretano de Combate ao Cancer, Ribeirao Preto, Brazil. FAU - Mattos, Cecilia Helena Peinado de Sampaio AU - Mattos CHPS AD - Department of Nutrition, IRPCC - Instituto Ribeiraopretano de Combate ao Cancer, Ribeirao Preto, Brazil. FAU - Santos, Evandro Airton Sordi Dos AU - Santos EASD AD - Department of Oncology, IRPCC - Instituto Ribeiraopretano de Combate ao Cancer, Ribeirao Preto, Brazil. FAU - Neto, Natael Ribeiro Malta AU - Neto NRM AD - Department of Oncology, Santa Casa de Misericordia de Passos, Passos, Brazil. FAU - Moreira, Raquel Pedro AU - Moreira RP AD - Department of Oncology, Santa Casa De Misericordia de Araraquara, Araraquara, Brazil. FAU - Luciara Tonelo Batella AU - Luciara Tonelo Batella AD - Instituto Ribeiraopretano de Combate ao Cancer, Ribeirao Preto, Brazil. FAU - Santos, Hellin Dos AU - Santos HD AD - Prodiet Clinical Nutrition, Curitiba, Brazil. FAU - Celes, Ana Paula Monnerat AU - Celes APM AD - Prodiet Clinical Nutrition, Curitiba, Brazil. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20200502 PL - United States TA - Nutr Cancer JT - Nutrition and cancer JID - 7905040 SB - IM MH - Chemoradiotherapy MH - Dietary Supplements MH - Energy Intake MH - Female MH - Humans MH - *Neoplasms/drug therapy MH - *Nutrition Therapy EDAT- 2020/05/05 06:00 MHDA- 2021/08/19 06:00 CRDT- 2020/05/05 06:00 PHST- 2020/05/05 06:00 [pubmed] PHST- 2021/08/19 06:00 [medline] PHST- 2020/05/05 06:00 [entrez] AID - 10.1080/01635581.2020.1758170 [doi] PST - ppublish SO - Nutr Cancer. 2021;73(3):442-449. doi: 10.1080/01635581.2020.1758170. Epub 2020 May 2.