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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Odense University Hospital
Sponsor:
Collaborators:
University of Southern Denmark
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Steffen Husby, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01766804
First received: January 9, 2013
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Acute Lymphoblastic Leukemia
Dietary Supplement: Bovine Colostrum
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Days with fever. Fever [ Time Frame: Measured two times daily and on suspicion during the intervention period, up to four weeks, ] [ Designated as safety issue: No ]
    Days with temperature at or above 38.5 degrees celsius.


Secondary Outcome Measures:
  • Days in intensive care unit [ Time Frame: During the 4 week intervention period ] [ Designated as safety issue: No ]
    Number of days treated in an intensive care unit.

  • Days in i.v. antibiotic treatment. [ Time Frame: During the 4 week intervention period. ] [ Designated as safety issue: No ]
    Number of days in intravenous antibiotic treatment during the intervention period.

  • Duration of cytopenia (neutrocytes <1,0 and platelets <20) [ Time Frame: During the 4 week intervention period. ] [ Designated as safety issue: No ]
  • Proven or suspected infections [ Time Frame: During the 4 week intervention period ] [ Designated as safety issue: No ]
    Episodes of suspected or culture positive sepsis number of documented septic events either culture proven or those treated with a course of antibiotics.

  • Number of blood and platelet transfusions given during the course of treatment [ Time Frame: During the 4 week intervention period. ] [ Designated as safety issue: No ]
    Number of blood and platelet transfusions given during the course of treatment

  • Clinical and paraclinical indices of gastrointestinal toxicity [ Time Frame: At base line and weekly during the 4 week intervention period. Up to 4 weeks. ] [ Designated as safety issue: No ]

    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 [ Time Frame: Weekly and at day 3 and 24, up to 4 weeks. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Colodan, Biodane-Pharma.
Placebo Comparator: Placebo
A daily placebo supplement consisting of whole milk powder and whey protein.
Dietary Supplement: placebo

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.

  Eligibility

Ages Eligible for Study:   1 Year to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Milk Allergy
  • Lactose intolerance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766804

Contacts
Contact: Mathias Rathe, MD +4530296665 mathias.rathe@ouh.regionsyddanmark.dk
Contact: Steffen Husby, MD, DMSc steffen.husby@ouh.regionsyddanmark.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Mathias Rathe, MD    +4530296665    mathias.rathe@ouh.regionsyddanmark.dk   
Principal Investigator: Mathias Rathe, MD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Mathias Rathe, MD    +4530296665    mathias.rathe@ouh.regionsyddanmark.dk   
Principal Investigator: Mathias Rathe, MD         
Sponsors and Collaborators
Steffen Husby
University of Southern Denmark
Rigshospitalet, 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
  More Information

No publications provided

Responsible Party: Steffen Husby, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01766804     History of Changes
Other Study ID Numbers: OUH-HCA-002
Study First Received: January 9, 2013
Last Updated: May 31, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Acute Lymphoblastic Leukemia
Bovine Colostrum
Inflammation
Infection
Toxicity

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014