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

July 30, 2018 updated by: Steffen Husby

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Milk Allergy
  • Lactose intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bovine colostrum
A daily supplement of bovine colostrum powder.
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.
Other Names:
  • Colodan, Biodane-Pharma.
Placebo Comparator: Placebo
A daily placebo supplement consisting of whole milk powder and whey protein.
Dietary supplement: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured two times daily and on suspicion during the intervention period, up to four weeks,

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days in intensive care unit
Time Frame: During the 4 week intervention period
Number of days treated in an intensive care unit.
During the 4 week intervention period
Days in i.v. antibiotic treatment.
Time Frame: During the 4 week intervention period.
Number of days in intravenous antibiotic treatment during the intervention period.
During the 4 week intervention period.
Duration of cytopenia (neutrocytes <1,0 and platelets <20)
Time Frame: During the 4 week intervention period.
During the 4 week intervention period.
Proven or suspected infections
Time Frame: 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.
During the 4 week intervention period
Number of blood and platelet transfusions given during the course of treatment
Time Frame: During the 4 week intervention period.
Number of blood and platelet transfusions given during the course of treatment
During the 4 week intervention period.
Clinical and paraclinical indices of gastrointestinal toxicity
Time Frame: 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,
At base line and weekly during the 4 week intervention period. Up to 4 weeks.
Serologic markers for systemic inflammation
Time Frame: 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.
Weekly and at day 3 and 24, up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steffen Husby

Collaborators

Rigshospitalet, Denmark
University of Southern Denmark

Investigators

  • Principal Investigator: Mathias Rathe, MD, University og Southern Denmark
  • Study Chair: Steffen Husby, MD, DMSc, Odense University Hospital
  • Study Chair: Klaus Müller, MD, DMSc, Rigshospitalet, Denmark
  • Study Chair: Peder S Wehner, MD, PhD, Odense University Hospital
  • Study Chair: Per T Sangild, DVSc, DMSc, Department of Human Nutrition, Faculty of Life Science, University of Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OUH-HCA-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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