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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Rigshospitalet, Denmark | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bovine colostrum | Experimental | A daily supplement of bovine colostrum powder. |
|
| Placebo | Placebo Comparator | A daily placebo supplement consisting of whole milk powder and whey protein. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, |
| Measure | Description | Time Frame |
|---|---|---|
| Days in intensive care unit | Number of days treated in an intensive care unit. | During the 4 week intervention period |
| Days in i.v. antibiotic treatment. | Number of days in intravenous antibiotic treatment during the intervention period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathias Rathe, MD | University og Southern Denmark | Principal Investigator |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30861163 | Derived | Rathe M, De Pietri S, Wehner PS, Frandsen TL, Grell K, Schmiegelow K, Sangild PT, Husby S, Muller K. Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia: A Randomized, Double-Blind, Placebo-Controlled Trial. JPEN J Parenter Enteral Nutr. 2020 Feb;44(2):337-347. doi: 10.1002/jpen.1528. Epub 2019 Mar 12. | |
| 27445347 |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007249 | Inflammation |
| D007239 | Infections |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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.
|
| placebo | Dietary Supplement |
|
| During the 4 week intervention period. |
| Duration of cytopenia (neutrocytes <1,0 and platelets <20) | During the 4 week intervention period. |
| 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 |
| 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. |
| 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. |
| 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. |
| Odense |
| 5000 |
| Denmark |
| Shen RL, Pontoppidan PE, Rathe M, Jiang P, Hansen CF, Buddington RK, Heegaard PM, Muller K, Sangild PT. Milk diets influence doxorubicin-induced intestinal toxicity in piglets. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G324-33. doi: 10.1152/ajpgi.00373.2015. Epub 2016 Jul 21. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |