Acute Lymphoblastic Leukemia
Conditions
Keywords
Acute Lymphoblastic Leukemia, Bovine Colostrum, Inflammation, Infection, Toxicity
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTBovine Colostrum
The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.
DIETARY_SUPPLEMENTplacebo
Sponsors
University of Southern Denmark
Rigshospitalet, Denmark
Steffen Husby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
1 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol
Exclusion criteria
* Milk Allergy * Lactose intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days with fever. Fever | Measured two times daily and on suspicion during the intervention period, up to four weeks, | Days with temperature at or above 38.5 degrees celsius. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days in i.v. antibiotic treatment. | During the 4 week intervention period. | Number of days in intravenous antibiotic treatment during the intervention period. |
| Duration of cytopenia (neutrocytes <1,0 and platelets <20) | During the 4 week intervention period. | — |
| Proven or suspected infections | During the 4 week 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. |
| Days in intensive care unit | During the 4 week intervention period | Number of days treated in an intensive care unit. |
| Clinical and paraclinical indices of gastrointestinal toxicity | At base line and weekly during the 4 week intervention period. Up to 4 weeks. | 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 | Weekly and at day 3 and 24, up to 4 weeks. | 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. |
| Number of blood and platelet transfusions given during the course of treatment | During the 4 week intervention period. | Number of blood and platelet transfusions given during the course of treatment |
Countries
Denmark
Outcome results
None listed