Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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,
Mathias Rathe, MD
University og Southern Denmark
Denmark: Danish Dataprotection Agency