Effects of individualized nutrition after allogeneic hematopoietic stem cell transplantation following myeloablative conditioning; a randomized controlled trial

Summary Background & aims Reduced quality of life (QoL) is prevalent after allogeneic hematopoietic stem cell transplantation (allo-HSCT). In this randomized trial we examined the effect of individualized nutritional support during hospitalization for allo-HSCT. Primary outcome was change in global QoL three months post-HSCT with oral mucositis (OM) and acute graft-versus-host disease (aGVHD) as main secondary outcomes. Methods Whereas the intervention group received recommended minimum daily intakes of 126 kJ/kg and 1.5–2.0 g protein/kg as food, supplements, enteral or parenteral nutrition, the controls received routine feeding. QoL was self-reported using the EORTC QLQ-C30 questionnaire. Results Between August, 2010 and February, 2016, we randomized 59 and 60 patients to intervention and control, respectively; 40 and 48 being eligible for analysis of QoL. There was no difference between the two groups in mean global QoL after three months (−3.10, 95% CI −11.90–5.69; P = 0.49). Nor were there any differences in OM grades 3 or 4 (RR (vs grades 0–2), 1.11, 95% CI 0.59–2.11 and 0.95, 95% CI 0.72–1.25, respectively; P = 0.78), or aGVHD grades 3 or 4 (RR (vs grades 0–2) 0.44, 95% CI 0.12–1.60; and 0.65, 95% CI 0.20–2.20, respectively; P = 0.37). Conclusion Individualized nutritional support with recommended energy and protein intakes during hospitalization had no effect on QoL, OM or aGVHD three months after allo-HSCT compared to routine nutrition.