Effect of Bovine Colostrum on Toxicity and Inflammatory Responses

Acute Lymphoblastic Leukemia Clinical Trial

— CALL  

Official title:

Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766804
• Other study ID #: OUH-HCA-002
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2018
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 45 Years

Eligibility

Inclusion Criteria:

• Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol

Exclusion Criteria:

• Milk Allergy

• Lactose intolerance

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Dietary Supplement:
• Bovine Colostrum
The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.
• placebo

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Steffen Husby	Rigshospitalet, Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,
Secondary	Days in intensive care unit	Number of days treated in an intensive care unit.	During the 4 week intervention period
Secondary	Days in i.v. antibiotic treatment.	Number of days in intravenous antibiotic treatment during the intervention period.	During the 4 week intervention period.
Secondary	Duration of cytopenia (neutrocytes <1,0 and platelets <20)		During the 4 week intervention period.
Secondary	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.	During the 4 week intervention period
Secondary	Number of blood and platelet transfusions given during the course of treatment	Number of blood and platelet transfusions given during the course of treatment	During the 4 week intervention period.
Secondary	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,	At base line and weekly during the 4 week intervention period. Up to 4 weeks.
Secondary	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.	Weekly and at day 3 and 24, up to 4 weeks.