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Completed

NCT Number: NCT01766804

Effect of Bovine Colostrum on Toxicity and Inflammatory Responses

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Inflammation Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Milk Allergy
  • Lactose intolerance

Treatment and study plan

Bovine colostrum

Dietary Supplement

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

Dietary Supplement

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Steffen Husby

Other

Collaborators

  • Rigshospitalet, Denmark
  • University of Southern Denmark

Registry information

Official study title

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

Acronym: CALL

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2013
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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