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

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ClinicalTrials.gov Identifier: NCT01766804
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : August 1, 2018
Sponsor:
Collaborators:
University of Southern Denmark
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Steffen Husby, Odense University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Dietary Supplement: Bovine Colostrum Dietary Supplement: placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia
Actual Study Start Date : March 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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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 Name: Colodan, Biodane-Pharma.
Placebo Comparator: Placebo
A daily placebo supplement consisting of whole milk powder and whey protein.
 Dietary Supplement: placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Days in intensive care unit [ Time Frame: During the 4 week intervention period ]
    Number of days treated in an intensive care unit.

  2. 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.

  3. Duration of cytopenia (neutrocytes <1,0 and platelets <20) [ Time Frame: During the 4 week intervention period. ]
  4. 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.

  5. 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

  6. 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,


  7. 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.



Eligibility Criteria
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Ages Eligible for Study:   1 Year to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766804


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Steffen Husby
University of Southern Denmark
Rigshospitalet, Denmark
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steffen Husby, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01766804    
Other Study ID Numbers: OUH-HCA-002
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Keywords provided by Steffen Husby, Odense University Hospital:
Acute Lymphoblastic Leukemia
Bovine Colostrum
Inflammation
Infection
Toxicity
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases