Mathias Rathe1,2, Silvia De Pietri3, Peder Skov Wehner1, Thomas Leth Frandsen3, Kathrine Grell3,4, Kjeld Schmiegelow3,5, Per Torp Sangild1,3,6, Steffen Husby1, Klaus Müller3,7. 1. Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark. 2. OPEN, Odense Patient Data Explorative Network, Odense University Hospital, Odense, Denmark. 3. Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 4. Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark. 5. Institute of Clinical Medicine, Faculty of Medicine, University of Copenhagen, Copenhagen, Denmark. 6. Section of Comparative Pediatrics and Nutrition, Department of Clinical Veterinary and Animal Science, University of Copenhagen, Copenhagen, Denmark. 7. Institute of Inflammation Research, Rigshospitalet, Copenhagen, Denmark.
Abstract
BACKGROUND: The toxic effect of chemotherapy on the gastrointestinal tract may lead to mucositis and is associated with the pathogenesis of other treatment-related complications. We hypothesized that nutrition supplementation with bovine colostrum, rich in bioactive factors, would ameliorate gastrointestinal toxicity and reduce the incidence of fever and infectious complications during induction treatment for childhood acute lymphoblastic leukemia (ALL). METHODS:Children with newly diagnosed ALL were included in a 2-center, randomized, double-blind, placebo-controlled clinical trial. Patients were randomized to receive a daily colostrum or placebo supplement during 4 weeks of induction treatment. Data on fever, bacteremia, need for antibiotics, and mucosal toxicity were prospectively collected. (Trial registration: www.clinicaltrials.gov NCT01766804). RESULTS:Sixty-two patients were included. No differences were found for the primary outcome (number of days with fever). No difference was observed for neutropenic fever, intravenous antibiotics, or incidence of bacteremia. Peak severity of oral mucositis was significantly reduced by colostrum (7/29 patients, 24% mild; 6/29, 21% moderate; 1/29, 3% severe) compared with placebo (12/31, 39% mild; 1/31, 3% moderate; 7/31, 23% severe) (P = 0.02). Among patients receiving at least 1 dose of supplement (colostrum: n = 22; placebo: n = 30), the peak weekly self-reported oral mucositis score was overall significantly less severe in the colostrum group (P = 0.009). CONCLUSION: The use of prophylactic bovine colostrum showed no effect on fever, infectious morbidity, or inflammatory responses. Nevertheless, these data may suggest protective effects on the oral mucosa during induction therapy in childhood ALL, encouraging additional studies confirming these findings.
RCT Entities:
BACKGROUND: The toxic effect of chemotherapy on the gastrointestinal tract may lead to mucositis and is associated with the pathogenesis of other treatment-related complications. We hypothesized that nutrition supplementation with bovine colostrum, rich in bioactive factors, would ameliorate gastrointestinal toxicity and reduce the incidence of fever and infectious complications during induction treatment for childhood acute lymphoblastic leukemia (ALL). METHODS:Children with newly diagnosed ALL were included in a 2-center, randomized, double-blind, placebo-controlled clinical trial. Patients were randomized to receive a daily colostrum or placebo supplement during 4 weeks of induction treatment. Data on fever, bacteremia, need for antibiotics, and mucosal toxicity were prospectively collected. (Trial registration: www.clinicaltrials.gov NCT01766804). RESULTS: Sixty-two patients were included. No differences were found for the primary outcome (number of days with fever). No difference was observed for neutropenic fever, intravenous antibiotics, or incidence of bacteremia. Peak severity of oral mucositis was significantly reduced by colostrum (7/29 patients, 24% mild; 6/29, 21% moderate; 1/29, 3% severe) compared with placebo (12/31, 39% mild; 1/31, 3% moderate; 7/31, 23% severe) (P = 0.02). Among patients receiving at least 1 dose of supplement (colostrum: n = 22; placebo: n = 30), the peak weekly self-reported oral mucositis score was overall significantly less severe in the colostrum group (P = 0.009). CONCLUSION: The use of prophylactic bovine colostrum showed no effect on fever, infectious morbidity, or inflammatory responses. Nevertheless, these data may suggest protective effects on the oral mucosa during induction therapy in childhood ALL, encouraging additional studies confirming these findings.
Authors: Maria C E Andersen; Malene W Johansen; Thomas Nissen; Anders B Nexoe; Gunvor I Madsen; Grith L Sorensen; Uffe Holmskov; Anders Schlosser; Jesper B Moeller; Steffen Husby; Mathias Rathe Journal: Support Care Cancer Date: 2020-09-12 Impact factor: 3.603
Authors: Dana C Mora; Grete Overvåg; Miek C Jong; Agnete E Kristoffersen; Debbie C Stavleu; Jianping Liu; Trine Stub Journal: BMC Complement Med Ther Date: 2022-04-02
Authors: Monica Guberti; Stefano Botti; Maria Teresa Capuzzo; Sara Nardozi; Andrea Fusco; Andrea Cera; Laura Dugo; Michela Piredda; Maria Grazia De Marinis Journal: Nutrients Date: 2021-06-25 Impact factor: 5.717