Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-02-20 @ 10:16 PM
Study NCT ID:
NCT01766804
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2013-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2013-01-09', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days with fever. Fever', 'timeFrame': 'Measured two times daily and on suspicion during the intervention period, up to four weeks,', 'description': 'Days with temperature at or above 38.5 degrees celsius.'}], 'secondaryOutcomes': [{'measure': 'Days in intensive care unit', 'timeFrame': 'During the 4 week intervention period', 'description': 'Number of days treated in an intensive care unit.'}, {'measure': 'Days in i.v. antibiotic treatment.', 'timeFrame': 'During the 4 week intervention period.', 'description': 'Number of days in intravenous antibiotic treatment during the intervention period.'}, {'measure': 'Duration of cytopenia (neutrocytes <1,0 and platelets <20)', 'timeFrame': 'During the 4 week intervention period.'}, {'measure': 'Proven or suspected infections', 'timeFrame': 'During the 4 week intervention period', 'description': 'Episodes of suspected or culture positive sepsis number of documented septic events either culture proven or those treated with a course of antibiotics.'}, {'measure': 'Number of blood and platelet transfusions given during the course of treatment', 'timeFrame': 'During the 4 week intervention period.', 'description': 'Number of blood and platelet transfusions given during the course of treatment'}, {'measure': 'Clinical and paraclinical indices of gastrointestinal toxicity', 'timeFrame': 'At base line and weekly during the 4 week intervention period. Up to 4 weeks.', 'description': '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).\n\nParaclinical indices are citruline, fecal calprotectin,'}, {'measure': 'Serologic markers for systemic inflammation', 'timeFrame': 'Weekly and at day 3 and 24, up to 4 weeks.', 'description': '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).\n\nCytokine 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Lymphoblastic Leukemia', 'Bovine Colostrum', 'Inflammation', 'Infection', 'Toxicity'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '30861163', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '27445347', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol\n\nExclusion Criteria:\n\n* Milk Allergy\n* Lactose intolerance'}, 'identificationModule': {'nctId': 'NCT01766804', 'acronym': 'CALL', 'briefTitle': 'Effect of Bovine Colostrum on Toxicity and Inflammatory Responses', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia', 'orgStudyIdInfo': {'id': 'OUH-HCA-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bovine colostrum', 'description': 'A daily supplement of bovine colostrum powder.', 'interventionNames': ['Dietary Supplement: Bovine Colostrum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A daily placebo supplement consisting of whole milk powder and whey protein.', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Bovine Colostrum', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Colodan, Biodane-Pharma.'], 'description': 'The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.', 'armGroupLabels': ['Bovine colostrum']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Mathias Rathe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University og Southern Denmark'}, {'name': 'Steffen Husby, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Odense University Hospital'}, {'name': 'Klaus Müller, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Peder S Wehner, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Odense University Hospital'}, {'name': 'Per T Sangild, DVSc, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Human Nutrition, Faculty of Life Science, University of Copenhagen, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steffen Husby', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Steffen Husby', 'investigatorAffiliation': 'Odense University Hospital'}}}}