Effect of Bovine Colostrum on Toxicity and Inflammatory Responses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Dietary Supplement: Bovine Colostrum
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol Exclusion Criteria: Milk Allergy Lactose intolerance

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bovine colostrum<br>A daily supplement of bovine colostrum powder. | Dietary Supplement: Bovine Colostrum<br>* The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.<br>* Other names: Colodan, Biodane-Pharma.;|
| Placebo Comparator: Placebo<br>A daily placebo supplement consisting of whole milk powder and whey protein. | Dietary Supplement: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days with fever. Fever | Days with temperature at or above 38.5 degrees celsius. | Measured two times daily and on suspicion during the intervention period, up to four weeks, | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days in intensive care unit | Number of days treated in an intensive care unit. | During the 4 week intervention period | 
| Days in i.v. antibiotic treatment. | Number of days in intravenous antibiotic treatment during the intervention period. | During the 4 week intervention period. | 
| Duration of cytopenia (neutrocytes <1,0 and platelets <20) |  | During the 4 week intervention period. | 
| Proven or suspected infections | Episodes of suspected or culture positive sepsis number of documented septic events either culture proven or those treated with a course of antibiotics. | During the 4 week intervention period | 
| Number of blood and platelet transfusions given during the course of treatment | Number of blood and platelet transfusions given during the course of treatment | During the 4 week intervention period. | 
| Clinical and paraclinical indices of gastrointestinal toxicity | 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, | At base line and weekly during the 4 week intervention period. Up to 4 weeks. | 
| Serologic markers for systemic inflammation | 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. | Weekly and at day 3 and 24, up to 4 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic Leukemia, Bovine Colostrum, Inflammation, Infection, Toxicity