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Whey Protein

A daily supplement of bovine colostrum powder.

A daily placebo supplement consisting of whole milk powder and whey protein.

The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.

Bovine Colostrum

placebo

Mathias Rathe, MD

Steffen Husby, MD, DMSc

Klaus Müller, MD, DMSc

Peder S Wehner, MD, PhD

Per T Sangild, DVSc, DMSc

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.

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.

Randomization was computer based in blocks of eight to ensure an equal number of participants in each randomization group. The randomization scheme was generated by using the web site Randomization.com ⟨http://www.randomization.com⟩. The randomization center was located at the same hospital as one of the recruitment sites (OUH). The randomization list was sent directly and exclusively to the research secretariat in charge of treatment allocation. Bovine colostrum or the placebo supplement was provided in identical foil sachets differing only in randomization code. Participants, their treating physicians, and any individual involved in the coordination and implementation of the trial were masked to treatment allocation.

Effect of Bovine Colostrum on Toxicity and Inflammatory Responses

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

Days with temperature at or above 38.5 degrees celsius.

Number of days treated in an intensive care unit.

Number of days in intravenous antibiotic treatment during the 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.

Number of blood and platelet transfusions given during the course of treatment

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,

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses	NCT01766804	Acute Lymphobla...	Bovine Colostru... placebo	1 Year - 45 Years	Odense University Hospital
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses	NCT01766804	Acute Lymphobla...	Bovine Colostru... placebo	1 Year - 45 Years	Odense University Hospital
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses	NCT01766804	Acute Lymphobla...	Bovine Colostru... placebo	1 Year - 45 Years	Odense University Hospital
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses	NCT01766804	Acute Lymphobla...	Bovine Colostru... placebo	1 Year - 45 Years	Odense University Hospital

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