Effect of Bovine Colostrum on Toxicity and Inflammatory Responses (CALL)

• Days with fever. Fever [ Time Frame: Measured two times daily and on suspicion during the intervention period, up to four weeks, ] [ Designated as safety issue: No ]
  Days with temperature at or above 38.5 degrees celsius.
  
  

• Days in intensive care unit [ Time Frame: During the 4 week intervention period ] [ Designated as safety issue: No ]
  Number of days treated in an intensive care unit.
  
  
• Days in i.v. antibiotic treatment. [ Time Frame: During the 4 week intervention period. ] [ Designated as safety issue: No ]
  Number of days in intravenous antibiotic treatment during the intervention period.
  
  
• Duration of cytopenia (neutrocytes <1,0 and platelets <20) [ Time Frame: During the 4 week intervention period. ] [ Designated as safety issue: No ]
  
• Proven or suspected infections [ Time Frame: During the 4 week intervention period ] [ Designated as safety issue: No ]
  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 [ Time Frame: During the 4 week intervention period. ] [ Designated as safety issue: No ]
  Number of blood and platelet transfusions given during the course of treatment
  
  
• Clinical and paraclinical indices of gastrointestinal toxicity [ Time Frame: At base line and weekly during the 4 week intervention period. Up to 4 weeks. ] [ Designated as safety issue: No ]

  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,

  
  
• Serologic markers for systemic inflammation [ Time Frame: Weekly and at day 3 and 24, up to 4 weeks. ] [ Designated as safety issue: No ]

  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.

  
  

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.