Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-19 @ 8:36 PM
Study NCT ID:
NCT06525402
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2024-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be conducted as a randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-23', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's International Mucositis Evaluation Scale", 'timeFrame': 'up to 16 days', 'description': "Tomlison et al. (2010) developed Children's International Mucositis Evaluation Scale (ChIMES) in order to evaluate the difficulty experienced by children with cancer due to mouth/throat pain developing depending on mucositis. Yavuz et al., (2011) conducted the validity and reliability study of the Turkish version of the scale. The scale consists of six (6) questions and it is an easy-to-apply form that can be answered with the child's facial expressions."}, {'measure': 'Oral Mucositis Evaluation Index of the World Health Organization', 'timeFrame': 'up to 16 days', 'description': 'It is scored between zero and four points. Although there is no change in the grade-0 mucosa, grade-1 painless ulcers, erythema or mild sensitivity, grade-2 painful erythema and ulcers, solid foods can be consumed. Grade-3 painful erythema, edema or ulcer can be consumed only, grade-4 ulceration, necrosis and hemorrhage are present, the patient cannot be fed, enteral or parenteral support is required.'}], 'secondaryOutcomes': [{'measure': 'Neutrophil count', 'timeFrame': 'up to 16 days', 'description': 'The neutrophil count will be evaluated. Numbers will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sodium Bicarbonate', 'Saline', 'Black Mulberry Syrup', 'Oral Mucositis', 'Chemotherapy', 'Children'], 'conditions': ['Oral Mucositis', 'Chemotherapy Effect']}, 'descriptionModule': {'briefSummary': 'This study was planned as a randomized controlled experimental study in order to compare the effects of oral care with saline and black mulberry syrup in addition to sodium bicarbonate on oral mucositis level in children aged 6-18 years receiving chemotherapy.', 'detailedDescription': "Oral mucositis, also known as stomatitis, is the most common complication of cancer treatment. Mucositis affects the patient's nutrition, daily functions, and quality of life, may compromise the ability to tolerate scheduled therapy. For this reason, the children to be included in the study will be randomly divided into three groups. Sodium bicarbonate, which is the routine care in the clinic, will be administered to the control group, and to the intervention groups, saline in addition to the routine care and black mulberry syrup will be applied in addition to the routine care. Data will be collected according to Patient Information Form, International Child Mucositis Assessment Scale (ChIMES), World Health Organization Mucositis Classification and neutrophil counts. Oral care will be applied to the groups 4 times a day for 14 days. The International Child Mucositis Rating Scale (ChIMES), World Health Organization Mucositis Classification and neutrophil counts will be evaluated by the researchers on the 1st, 2nd, 4th, 8th and 16th days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The willingness of the family and the child to participate in the study\n* Parent and child have separately informed written consent form\n* Be between 6-18 years old\n* Receiving chemotherapy and being hospitalized for chemotherapy treatment\n* Being fed orally\n\nExclusion Criteria:\n\n* Oral mucositis in the first intraoral evaluation\n* Having diabetes\n* Receiving radiotherapy\n* Having a surgical procedure in the mouth and jaw area\n* Receiving steroid therapy during chemotherapy treatment\n* Using a method other than the methods used in the study to protect the oral mucous membrane throughout the study'}, 'identificationModule': {'nctId': 'NCT06525402', 'briefTitle': 'Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Burdur Mehmet Akif Ersoy University'}, 'officialTitle': 'The Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on The Degree of Oral Mucositis in Children Receiving Chemotherapy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022/73'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium Bicarbonate Group (Usual care)', 'description': 'General routine oral care. In the clinic where the research was conducted, a guideline is routinely applied for the care of oral mucositis in line with the stages of oral mucositis. Sodium bicarbonate is used in line with this guideline. The first group will receive routine oral care in the clinic with sodium bicarbonate. It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night.', 'interventionNames': ['Other: Sodium Bicarbonate Group (Usual care)']}, {'type': 'EXPERIMENTAL', 'label': 'Saline Group', 'description': 'It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night.', 'interventionNames': ['Other: Saline Group']}, {'type': 'EXPERIMENTAL', 'label': 'Black Mulberry Syrup Group', 'description': 'It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night.', 'interventionNames': ['Other: Black Mulberry Syrup Group']}], 'interventions': [{'name': 'Sodium Bicarbonate Group (Usual care)', 'type': 'OTHER', 'description': 'In the clinic where the research was conducted, a guideline is routinely applied for the care of oral mucositis in line with the stages of oral mucositis. Sodium bicarbonate is used in line with this guideline. The first group, the control group, will receive routine oral care in the clinic with sodium bicarbonate. Oral care will be applied 4 times a day for 14 days.', 'armGroupLabels': ['Sodium Bicarbonate Group (Usual care)']}, {'name': 'Saline Group', 'type': 'OTHER', 'description': 'The second group, the experimental group, will first receive oral care routinely applied in the clinic. Then, oral care will be given in the form of 5 ml mouthwash with saline. Oral care will be applied 4 times a day for 14 days.', 'armGroupLabels': ['Saline Group']}, {'name': 'Black Mulberry Syrup Group', 'type': 'OTHER', 'description': 'The third group, the experimental group, will first receive oral care routinely applied in the clinic. Then black mulberry syrup will be applied. Then, oral care will be given in the form of 5 ml mouthwash with black mulberry syrup. Oral care will be applied 4 times a day for 14 days.', 'armGroupLabels': ['Black Mulberry Syrup Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isparta', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Selda Ateş Beşirik, Assistant Prof.', 'role': 'CONTACT', 'email': 'seldaates07@gmail.com', 'phone': '+905543683323'}], 'facility': 'Isparta City Hospital', 'geoPoint': {'lat': 37.76444, 'lon': 30.55222}}], 'centralContacts': [{'name': 'Selda Ateş Beşirik, Assistant Professor', 'role': 'CONTACT', 'email': 'seldaates07@gmail.com', 'phone': '+905543683323'}], 'overallOfficials': [{'name': 'Selda Ateş Beşirik, Assistant Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Burdur Mehmet Akif Ersoy University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burdur Mehmet Akif Ersoy University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Selda Ateş Beşirik', 'investigatorAffiliation': 'Burdur Mehmet Akif Ersoy University'}}}}