Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Days with fever. Fever
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, 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 Criteria
- Ages
- 1 Year to 45 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Bovine colostrum
A daily supplement of bovine colostrum powder.
Intervention: Bovine Colostrum (Dietary Supplement)
Placebo
A daily placebo supplement consisting of whole milk powder and whey protein.
Intervention: placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Days with fever. Fever
Time Frame: 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 Outcomes
- Number of blood and platelet transfusions given during the course of treatment(During the 4 week intervention period.)
- Days in intensive care unit(During the 4 week intervention period)
- Proven or suspected infections(During the 4 week intervention period)
- Serologic markers for systemic inflammation(Weekly and at day 3 and 24, up to 4 weeks.)
- Days in i.v. antibiotic treatment.(During the 4 week intervention period.)
- Duration of cytopenia (neutrocytes <1,0 and platelets <20)(During the 4 week intervention period.)
- Clinical and paraclinical indices of gastrointestinal toxicity(At base line and weekly during the 4 week intervention period. Up to 4 weeks.)
Investigators
Steffen Husby
Professor
Odense University Hospital