Effect of Bovine Colostrum on Toxicity and Inflammatory Responses

Not Applicable

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Bovine Colostrum

• Registration Number: NCT01766804
• Lead Sponsor: Steffen Husby

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.

Study Timeline

• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Study Start: 2013-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

Exclusion Criteria

• Milk Allergy
• Lactose intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	A daily placebo supplement consisting of whole milk powder and whey protein.
Bovine colostrum	Bovine Colostrum	A daily supplement of bovine colostrum powder.

Primary Outcome Measures

Name	Time	Method
Days with fever. Fever	Measured two times daily and on suspicion during the intervention period, up to four weeks,	Days with temperature at or above 38.5 degrees celsius.

Secondary Outcome Measures

Name	Time	Method
Number of blood and platelet transfusions given during the course of treatment	During the 4 week intervention period.	Number of blood and platelet transfusions given during the course of treatment
Days in intensive care unit	During the 4 week intervention period	Number of days treated in an intensive care unit.
Proven or suspected infections	During the 4 week intervention period	Episodes of suspected or culture positive sepsis number of documented septic events either culture proven or those treated with a course of antibiotics.
Serologic markers for systemic inflammation	Weekly and at day 3 and 24, up to 4 weeks.	Serum will be taken weekly. Markers will include C reactive protein (CRP), procalcitonin (PCT), soluble urokinase plasminogen activator receptor (sUPAR), plasma cytokines and receptors (IL-6, IL-8, Soluble tumour necrosis factor receptors (sTNFR1), IL-1Ra).; Cytokine production in full blood cultures will be measured at day 3 and at day 24. Initial screening for a broad spectrum of cytokines will be performed in 5-10 patients. Based on these results a final panel of analyses comprising a narrower spectrum of cytokines will be determined and used for further investigation. These will include at least TNFR1, IL-1Ra, IL-6, IL-8.
Days in i.v. antibiotic treatment.	During the 4 week intervention period.	Number of days in intravenous antibiotic treatment during the intervention period.
Duration of cytopenia (neutrocytes <1,0 and platelets <20)	During the 4 week intervention period.
Clinical and paraclinical indices of gastrointestinal toxicity	At base line and weekly during the 4 week intervention period. Up to 4 weeks.	Clinical toxicity is scored using Common Toxicity Criteria for Adverse Effects (NCI-CTCAE), WHO and oral mucositis assessment scale (OMAS) grading schemes at inclusion and weekly during the treatment period. Furthermore the patients register toxicity using the oral mucositis daily questionaire(OMDQ).; Paraclinical indices are citruline, fecal calprotectin,

Trial Locations

Locations (2)

Odense University Hospital; 🇩🇰 Odense, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark