Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-16 @ 9:14 AM
Study NCT ID:
NCT07300735
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2025-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009503', 'term': 'Neutropenia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017336', 'term': 'Loratadine'}], 'ancestors': [{'id': 'D003533', 'term': 'Cyproheptadine'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a parallel-group, randomized, open-label clinical trial comparing four interventions for the prevention of G-CSF-induced bone pain: no specific treatment (control), loratadine, diosmin-hesperidin, and the combination of loratadine and diosmin-hesperidin. Participants will be randomly assigned to one of the four groups and will receive their assigned treatment for 5 days.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Pain Severity (Brief Pain Inventory)', 'timeFrame': 'Baseline (before first dose of Filgrastim), 24 hours after first Filgrastim dose, and 5 days after treatment initiation.', 'description': 'This will be measured using the validated Brief Pain Inventory (BPI), which assesses pain intensity (e.g., worst pain, average pain). BPI pain severity will be compared for each trial arm. BPI pain severity will be compared as a composite score (sum of individual pain values divided by 4).\n\nA score ranging from 0 (no pain) to 10 (worst pain imaginable).'}, {'measure': 'Bone Pain Interference (Brief Pain Inventory)', 'timeFrame': 'Baseline (before first dose of Filgrastim), 24 hours after first Filgrastim dose, and 5 days after treatment initiation.', 'description': 'This will be measured using the validated Brief Pain Inventory (BPI), which assesses the degree to which pain interferes with daily life. BPI pain Interference will be compared for each trial arm. BPI pain interference will be compared as a composite score (sum of individual pain interference values divided by 7).\n\nA scale of 0 (does not interfere) to 10 (completely interferes).'}, {'measure': 'Change in Serum Tumor Necrosis Factor-alpha (TNF-alpha) Levels', 'timeFrame': '24 hours after first Filgrastim dose, and After 5 days of the intervention period', 'description': 'Serum TNF-alpha (pg/mL) is an inflammatory cytokine level measured in the blood that is hypothesized to be elevated in G-CSF induced bone pain. The change from baseline levels will be compared across the four study arms to determine the biological effect of the interventions. Lower levels of TNF-alpha are indicative of a reduction in the inflammatory response.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Loratadine', 'Diosmin', 'Filgrastim', 'Granulocyte Colony Stimulating Factor', 'G-CSF Induced Bone Pain', 'Hesperidin', 'Flavonoid', 'Antihistamine', 'Prophylaxis', 'Randomized Controlled Trial'], 'conditions': ['Hematologic Malignancy', 'Neutropenia', 'Bone Pain']}, 'descriptionModule': {'briefSummary': 'This is a comparative interventional study to determine the best way to prevent G-CSF induced bone pain in patients with hematological malignancies (blood cancers). G-CSF (Granulocyte Colony-Stimulating Factor) is a drug commonly used in these patients to boost white blood cell production, but it frequently causes severe bone pain.\n\nThe study is comparing two oral medications for their effectiveness as a preventive treatment:\n\n* Diosmin-Hesperidin (a flavonoid supplement).\n* Loratadine (a common anti-allergy medication).\n\nThe core question the study is trying to answer is:\n\n* Is diosmin-hesperidin effective in preventing G-CSF-induced bone pain compared to loratadine?\n* Does the combination of diosmin-hesperidin and loratadine offer better pain prevention than either drug alone?', 'detailedDescription': 'This is a prospective, controlled, randomized, and open-label clinical trial conducted at Alexandria University Hospitals to compare the efficacy of diosmin-hesperidin versus loratadine, and their combination, for the prevention of G-CSF-induced bone pain in adult patients (18-65 years) with hematological malignancies (leukemia or lymphoma) receiving filgrastim.\n\nRationale:\n\nG-CSF-induced bone pain is a common and debilitating side effect, impacting patient quality of life. While current management strategies using NSAIDs and antihistamines are not always sufficient, diosmin, a flavonoid with known anti-inflammatory and neuroprotective properties, has not been thoroughly investigated for this indication. This study aims to address this gap and explore the potential of diosmin, loratadine, and their combination to mitigate G-CSF-induced bone pain.\n\nStudy Design:\n\nParticipants meeting the eligibility criteria (detailed elsewhere) will be randomly assigned to one of four treatment groups:\n\nControl Group: No specific treatment for bone pain. Loratadine Group: Loratadine 10mg tablet once daily, administered 30 minutes before filgrastim and continued for 5 days.\n\nDiosmin-Hesperidin Group: Diosmin-Hesperidin 500mg tablet twice daily, administered 30 minutes before filgrastim and continued for 5 days.\n\nCombination Group: Loratadine 10mg tablet once daily plus Diosmin-Hesperidin 500mg tablet twice daily, administered 30 minutes before filgrastim and continued for 5 days.\n\nFilgrastim will be administered according to standard clinical practice for the underlying hematological condition.\n\nAssessments:\n\nBaseline Assessment: Before the start of filgrastim administration, demographic data, medical history (including type of malignancy, comorbidities, prior G-CSF treatment, and chemotherapy details), baseline laboratory tests (CBC, CRP, liver and kidney function), and baseline pain assessment using the Brief Pain Inventory (BPI) will be collected.\n\nFollow-up Assessments:\n\nWithin 24 hours of the first filgrastim dose, pain will be assessed using the BPI, and baseline TNF-alpha levels will be measured.\n\nAfter 5 days of treatment, follow-up laboratory tests (including TNF-alpha levels) and pain assessment using the BPI will be conducted.\n\nPrimary Outcome:\n\nThe primary outcome is to compare the effectiveness of diosmin-hesperidin, loratadine, and their combination in preventing G-CSF-induced bone pain. This will be assessed by changes in pain frequency and severity (measured by the BPI) and changes in serum TNF-alpha levels.\n\nSecondary Outcome:\n\nThe secondary outcome is to identify risk factors associated with the frequency and severity of G-CSF-induced bone pain.\n\nStatistical Analysis:\n\nData will be analyzed using IBM SPSS version 26. Appropriate statistical tests will be used to compare the treatment groups and assess the relationships between variables.\n\nEthical Considerations:\n\nThe study will be conducted in accordance with the Declaration of Helsinki and will be subject to approval by the Ethics Committee of Alexandria University. All participants will provide written informed consent before enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 to 65 years old\n* Receiving a G-CSF for one of the following indications:\n\nTreatment of neutropenia along with treatment for leukemia or lymphoma Neutropenia prevention following autologous hematopoietic cell transplant\n\n* Patients with or without bone pain associated with G-CSF administration.\n* Willingness to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with solid tumors.\n* Pregnant or breastfeeding women.\n* Patients with known allergies or hypersensitivity to Loratadine, Diosmin- Hespiridin or Filgrastim.\n* Patients with pre-existing bone disorders or receiving bone modifying agents\n* Chronic use of antihistamines, Diosmin-Hespiridin, NSAIDs, corticosteroids, or immunosuppressants.\n* Receiving medications with drug interaction grade X with Loratadine, Diosmin-Hespiridin or Filgrastim\n* Patients who are unable to understand or provide informed consent'}, 'identificationModule': {'nctId': 'NCT07300735', 'briefTitle': 'Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'A Comparative Study of Diosmin-Hesperidin and Loratadine for the Prevention of G-CSF Induced Bone Pain in Patients With Hematological Malignancies', 'orgStudyIdInfo': {'id': 'IRB NO:00012098'}, 'secondaryIdInfos': [{'id': 'Serial Number: 0108746', 'type': 'OTHER', 'domain': 'Ethics Committee Faculty of Medicine Alexandria University'}, {'id': 'FWA Number: 00018699', 'type': 'OTHER', 'domain': 'Ethics Committee Faculty of Medicine Alexandria University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in this arm will receive standard supportive care for G-CSF-induced bone pain, but will not receive the study interventions (loratadine or diosmin-hesperidin).'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Participants in this arm will receive loratadine 10mg tablets once daily, 30 minutes before filgrastim administration, for 5 days.', 'interventionNames': ['Drug: Loratadine']}, {'type': 'EXPERIMENTAL', 'label': 'Diosmin-Hesperidin', 'description': 'Participants in this arm will receive diosmin-hesperidin 500mg tablets twice daily, 30 minutes before filgrastim administration, for 5 days.', 'interventionNames': ['Drug: Diosmin-Hesperidin']}, {'type': 'EXPERIMENTAL', 'label': 'Loratadine + Diosmin-Hesperidin', 'description': 'Participants in this arm will receive loratadine 10mg tablets once daily plus diosmin-hesperidin 500mg tablets twice daily, 30 minutes before filgrastim administration, for 5 days.', 'interventionNames': ['Drug: Loratadine + Diosmin-Hesperidin']}], 'interventions': [{'name': 'Loratadine', 'type': 'DRUG', 'description': 'Loratadine 10 mg oral tablet administered once daily, starting 30 minutes before filgrastim administration and continued for 5 consecutive days.', 'armGroupLabels': ['Intervention']}, {'name': 'Diosmin-Hesperidin', 'type': 'DRUG', 'description': 'Diosmin-Hesperidin 500 mg oral tablet administered twice daily, starting 30 minutes before daily filgrastim administration and continued for 5 consecutive days.', 'armGroupLabels': ['Diosmin-Hesperidin']}, {'name': 'Loratadine + Diosmin-Hesperidin', 'type': 'DRUG', 'description': 'Combination of Loratadine 10 mg oral tablet once daily plus Diosmin-Hesperidin 500 mg oral tablet twice daily, starting 30 minutes before daily filgrastim administration and continued for 5 consecutive days.', 'armGroupLabels': ['Loratadine + Diosmin-Hesperidin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21532', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria University Hospitals', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Mai Moustafa Helmy, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Pharmacy, Alexandria University'}, {'name': 'Omar Mohamed Ghallab, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alexandria'}, {'name': 'Reham AbdelHalem Abo Elwafa, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alexandria'}, {'name': 'Noha Alaa Eldin Hamdy, Assistant professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Pharmacy, Alexandria University'}, {'name': 'Mayssaa Mohamed Elsayed, pharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Pharmacy, Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}