Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia

A Randomized, Double-Blind, Placebo-Controlled Trial

Mathias Rathe, Silvia De Pietri, Peder Skov Wehner, Thomas Leth Frandsen, Kathrine Grell, Kjeld Schmiegelow, Per Torp Sangild, Steffen Husby, Klaus Müller

Research output: Contribution to journalJournal articleResearchpeer-review

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.

Original languageEnglish
JournalJournal of Parenteral and Enteral Nutrition
ISSN0148-6071
DOIs
Publication statusE-pub ahead of print - 12. Mar 2019

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Colostrum
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Placebos
Mucositis
Poisons
Incidence
Controlled Clinical Trials
Mouth Mucosa
Gastrointestinal Tract

Keywords

  • enteral formulas
  • enteral nutrition
  • immunonutrition
  • life cycle
  • nutrition
  • oncology
  • pediatrics
  • research and diseases

Cite this

@article{039f70ded0154ecb89b8279a35a0d4a5,
title = "Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia: A Randomized, Double-Blind, Placebo-Controlled Trial",
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.",
keywords = "enteral formulas, enteral nutrition, immunonutrition, life cycle, nutrition, oncology, pediatrics, research and diseases",
author = "Mathias Rathe and {De Pietri}, Silvia and Wehner, {Peder Skov} and Frandsen, {Thomas Leth} and Kathrine Grell and Kjeld Schmiegelow and Sangild, {Per Torp} and Steffen Husby and Klaus M{\"u}ller",
note = "{\circledC} 2019 American Society for Parenteral and Enteral Nutrition.",
year = "2019",
month = "3",
day = "12",
doi = "10.1002/jpen.1528",
language = "English",
journal = "Journal of Parenteral and Enteral Nutrition",
issn = "0148-6071",
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Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia : A Randomized, Double-Blind, Placebo-Controlled Trial. / Rathe, Mathias; De Pietri, Silvia; Wehner, Peder Skov; Frandsen, Thomas Leth; Grell, Kathrine; Schmiegelow, Kjeld; Sangild, Per Torp; Husby, Steffen; Müller, Klaus.

In: Journal of Parenteral and Enteral Nutrition, 12.03.2019.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia

T2 - A Randomized, Double-Blind, Placebo-Controlled Trial

AU - Rathe, Mathias

AU - De Pietri, Silvia

AU - Wehner, Peder Skov

AU - Frandsen, Thomas Leth

AU - Grell, Kathrine

AU - Schmiegelow, Kjeld

AU - Sangild, Per Torp

AU - Husby, Steffen

AU - Müller, Klaus

N1 - © 2019 American Society for Parenteral and Enteral Nutrition.

PY - 2019/3/12

Y1 - 2019/3/12

N2 - 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.

AB - 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.

KW - enteral formulas

KW - enteral nutrition

KW - immunonutrition

KW - life cycle

KW - nutrition

KW - oncology

KW - pediatrics

KW - research and diseases

U2 - 10.1002/jpen.1528

DO - 10.1002/jpen.1528

M3 - Journal article

JO - Journal of Parenteral and Enteral Nutrition

JF - Journal of Parenteral and Enteral Nutrition

SN - 0148-6071

ER -