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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Days with fever. Fever
Days with temperature at or above 38.5 degrees celsius.
Time frame: Measured two times daily and on suspicion during the intervention period, up to four weeks,
Days in intensive care unit
Number of days treated in an intensive care unit.
Time frame: During the 4 week intervention period
Days in i.v. antibiotic treatment.
Number of days in intravenous antibiotic treatment during the intervention period.
Time frame: During the 4 week intervention period.
Duration of cytopenia (neutrocytes <1,0 and platelets <20)
Time frame: 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.
Time frame: 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
Time frame: 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,
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Time frame: 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.
Time frame: Weekly and at day 3 and 24, up to 4 weeks.