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

Abstract

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®) during oncologic treatment.

Methods: 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.

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.

Authors Contributions

A.A.F. and C.H.P.d.S.M. conceived and designed the study and participated in the analysis and discussion of the results and drafting of the article. E.A.S.d.S., N.R.M.N., and R.P.M. participated in data collection and contributed to the analysis and discussion of data. L.T.B. was the data manager. H.S. and A.P.M.C. participated in the analysis and discussion of data. All authors revised and agreed with the final version of this manuscript.

Acknowledgment

We would like to thank all the participants of the study and their families, including the nutritionists Gisele C. Carvalho and Camila R. Silva, for their contributions in data collection and patient care.

Disclosure Statement

A.P.M.C. is the Prodiet technical director, and H.S. the scientific specialist from Prodiet. The other authors report no potential conflict of interest.

References

Additional information

Funding

This study was sponsored by Prodiet Clinical Nutrition, producer of IMMAX, which provided the supplement and financial support to the centers that participated in the study.