Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-01-02 @ 4:20 AM
Study NCT ID:
NCT01789658
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2013-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'During hospitalization in connection with HSCT, an expected average of 25 days', 'description': 'Days with, and dose of morphine-equivalent opioids'}, {'measure': 'Duration of parenteral nutrition', 'timeFrame': 'During hospitalization in connection with HSCT, an expected average of 25 days', 'description': 'Days with Total Parenteral Nutrition'}, {'measure': 'Weight Loss', 'timeFrame': 'During hospitalization in connection with HSCT, an expected average of 25 days', 'description': 'Weight Loss in kilograms from admission to date of engraftment'}, {'measure': 'Duration of Antibiotic treatment', 'timeFrame': 'During hospitalization in connection with HSCT, an expected average of 25 days', 'description': 'Days with antibiotics'}, {'measure': 'Duration of febrile neutropenia', 'timeFrame': 'Until engraftment, an expected average of 20 days', 'description': 'Days with fever \\>38.0 degrees'}, {'measure': 'Duration of Hospitalisation', 'timeFrame': 'During hospitalization in connection with HSCT, an expected average of 25 days', 'description': 'Counted from day 0 until discharge either home or to region hospital.'}, {'measure': 'C reactive protein', 'timeFrame': 'During hospitalization in connection with HSCT, an expected average of 25 days', 'description': 'Level of p-CRP in comparison to grade of mucositis'}, {'measure': 'S-Albumin', 'timeFrame': 'During hospitalization in connection with HSCT, an expected average of 25 days', 'description': 'In correlation to grade of Oral Mucositis'}], 'primaryOutcomes': [{'measure': 'Mucositis grade - WHO Oral Toxicity Scale', 'timeFrame': 'Daily until engraftment, an expected average of 20 days.', 'description': 'WHO-Oral toxicity scale Grade 0 - No mucositis Grade 1 - Erythema and/or soreness Grade 2 - Erythema and/or ulcers. Can eat solid food. Grade 3 - Erythema and/or Ulcers. No solid food but can ingest liquids. Grade 4 - Oral alimentation not possible.'}], 'secondaryOutcomes': [{'measure': 'Mucositis grade - Children´s International Mucositis Evaluation Scale (ChiMES)', 'timeFrame': 'Daily until engraftment, an expected average of 20 days.', 'description': 'Daily evaluation by child and parent.'}, {'measure': 'Pain - Childrens Hospital Eastern Ontario Pain Scale (CHEOPS)', 'timeFrame': 'Daily until Engraftment an expected average of 20 days.', 'description': 'Daily assessment by nurse'}, {'measure': 'Mouth Pain', 'timeFrame': 'Daily until Engraftment an expected average of 20 days', 'description': 'Mouth Pain measured with Numerical Rating scale(NRS)for children \\>7 years and parents and Facial Pain Scale(FPS) for children \\< 7 years'}, {'measure': 'Emotional and Psychological status', 'timeFrame': 'Daily until engraftment, an expected average of 20 days.', 'description': 'Beck youth inventories for depression and anxiety'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oral Mucositis', 'Children', 'Cryotherapy', 'Hematopoietic Stem Cell Transplantation'], 'conditions': ['Oral Mucositis', 'Pain', 'Infection', 'Nutrition Aspect of Cancer']}, 'referencesModule': {'references': [{'pmid': '31993753', 'type': 'DERIVED', 'citation': 'Kamsvag T, Svanberg A, Legert KG, Arvidson J, von Essen L, Mellgren K, Toporski J, Winiarski J, Ljungman G. Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations-a feasibility study and randomized controlled trial. Support Care Cancer. 2020 Oct;28(10):4869-4879. doi: 10.1007/s00520-019-05258-2. Epub 2020 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and conditioning regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this study is to effectiveness of cryotherapy as a prophylactic treatment in children undergoing HSCT.', 'detailedDescription': "There is a complex pathobiology behind OM; chemo and radiotherapy affects the mucosa and submucosa causing DNA-strand brakes and generation of reactive oxygen species (ROS). This initiates a cascade of events, among others activation of transcription factors, up-regulation of pro-inflammatory cytokines, and activation of macrophages and proteases leading to tissue injury causing symptoms such as erythema, edema, ulceration, taste perception alterations, and mouth dryness. OM often causes local and systemic infections, fatigue, pain, and difficulties in basal functions such as swallowing (and hence drinking and eating) and talking and reduces patients' psychological well-being. Nearly 90 % of pediatric patients undergoing HSCT are afflicted with OM. In pediatric patients mucositis is reported as one of the most painful and debilitating side effects during cancer treatment.Beyond a significant suffering for the patient it is hence associated with higher costs for health care and increased mortality.\n\nThe current scientific situation regarding prevention and treatment of OM has been summarized in Cochrane reports showing limited data on adults and practically missing data on children and adolescents. Concluding guidelines from these reports emphasize the need for well conducted randomized controlled trials (RCT's) to evaluate and refine treatments in order to establish evidence based interventions.\n\nThe use of cryotherapy to prevent oral mucositis in patients who are receiving high-dose chemotherapy as a conditioning agent prior to HSCT continue to show evidence in the adult population.\n\nThe aim of this study is to compare treatment with cryotherapy (Arm 1)with a standard oral care protocal (Arm 2)\n\nARM 1 Children are instructed to use chew on ice-chips, ingest ice-cream or ice-water during infusion of chemotherapy as part of the conditioning treatment prior to HSCT. Melted ice should be replaced by new as soon as possible. Children receiving a 24-hour infusion are instructed to use cryotherapy for one hour 4 times a day.\n\nARM 2 Standard care for prevention and management of oral mucositis\n\nPrimary outcome\n\n* Degree and duration of Oral mucositis\n\nSecondary outcomes\n\n* Oral pain\n* Opioid use\n* Duration of parenteral nutrition\n* Weight loss\n* Duration of neutropenic fever\n* Duration of antibiotic treatment\n* Duration of hospitalization\n* Emotional and psychological status\n* C reactive protein (CRP) and s-albumin correlation to grade of Oral Mucositis"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge between 4-18 Undergoing Hematopoietic Stem Cell Transplantation in Sweden sufficient knowledge in swedish to understand the protocols -\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01789658', 'briefTitle': 'Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'A Randomized Controlled Trial of Cryotherapy for Prevention and Reduction of Severity of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation.', 'orgStudyIdInfo': {'id': 'UU-OM-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryotherapy', 'description': 'Cryotherapy during conditioning treatment with chemotherapy prior to HSCT', 'interventionNames': ['Other: Cryotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard oral Care. No Cryotherapy during conditioning treatment prior to HSCT'}], 'interventions': [{'name': 'Cryotherapy', 'type': 'OTHER', 'description': 'Cryotherapy with ice-chips, ice cream or ice water is given during conditioning treatment with chemotherapy prior to HSCT.', 'armGroupLabels': ['Cryotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-41685', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Pediatric Oncology Department, Queen Silvia Childrens´ Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': 'SE-22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Departent of Pediatric Oncology, Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': 'SE-14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Center for Allogeneic Stem Cell Transplantation, Karolinska University Hospital, Hudding', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'Se-14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of pediatrics B78, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'SE-75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Department of Hematology, Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Gustaf Ljungman, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uppsala University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Swedish Childhood Cancer Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}