Clinical trial NCT01766804: Effect of Bovine Colostrum on Toxicity and Inflammatory Responses
Official title: Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
Bovine Colostrum
Inflammation
Infection
Toxicity
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Rigshospitalet, Denmark
First posted: 2013-01-11
Enrollment: 62
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.

Detailed description: Acute lymphoblastic leukaemia (ALL) is the most common form of childhood cancers. Cure rates are improving, but the intensity of treatment is limited by toxicity. 2-5% of patients die of treatment related complications, mostly related to therapy-induced toxicity and immune suppression. The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation. The study is based on patients treated according to the current NOPHO protocol.

Eligibility criteria: Inclusion Criteria:

* Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol

Exclusion Criteria:

* Milk Allergy
* Lactose intolerance

Primary outcomes:
measure: Days with fever. Fever
timeFrame: Measured two times daily and on suspicion during the intervention period, up to four weeks,
Secondary outcomes:
measure: Days in intensive care unit
timeFrame: During the 4 week intervention period
measure: Days in i.v. antibiotic treatment.
timeFrame: During the 4 week intervention period.
measure: Duration of cytopenia (neutrocytes <1,0 and platelets <20)
timeFrame: During the 4 week intervention period.
measure: Proven or suspected infections
timeFrame: During the 4 week intervention period
measure: Number of blood and platelet transfusions given during the course of treatment
timeFrame: During the 4 week intervention period.
measure: Clinical and paraclinical indices of gastrointestinal toxicity
timeFrame: At base line and weekly during the 4 week intervention period. Up to 4 weeks.
measure: Serologic markers for systemic inflammation
timeFrame: Weekly and at day 3 and 24, up to 4 weeks.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: University og Southern Denmark
name: Mathias Rathe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Steffen Husby, MD, DMSc
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Klaus Müller, MD, DMSc
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Peder S Wehner, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Human Nutrition, Faculty of Life Science, University of Copenhagen, Denmark
name: Per T Sangild, DVSc, DMSc
role: STUDY_CHAIR
References:
citation: Rathe M, De Pietri S, Wehner PS, Frandsen TL, Grell K, Schmiegelow K, Sangild PT, Husby S, Muller K. Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia: A Randomized, Double-Blind, Placebo-Controlled Trial. JPEN J Parenter Enteral Nutr. 2020 Feb;44(2):337-347. doi: 10.1002/jpen.1528. Epub 2019 Mar 12.
citation: Shen RL, Pontoppidan PE, Rathe M, Jiang P, Hansen CF, Buddington RK, Heegaard PM, Muller K, Sangild PT. Milk diets influence doxorubicin-induced intestinal toxicity in piglets. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G324-33. doi: 10.1152/ajpgi.00373.2015. Epub 2016 Jul 21.