Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood Cancers
NCT ID: NCT07300735
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
88 participants
INTERVENTIONAL
2025-03-01
2026-07-31
Brief Summary
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The study is comparing two oral medications for their effectiveness as a preventive treatment:
* Diosmin-Hesperidin (a flavonoid supplement).
* Loratadine (a common anti-allergy medication).
The core question the study is trying to answer is:
* Is diosmin-hesperidin effective in preventing G-CSF-induced bone pain compared to loratadine?
* Does the combination of diosmin-hesperidin and loratadine offer better pain prevention than either drug alone?
Detailed Description
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Rationale:
G-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.
Study Design:
Participants meeting the eligibility criteria (detailed elsewhere) will be randomly assigned to one of four treatment groups:
Control Group: No specific treatment for bone pain. Loratadine Group: Loratadine 10mg tablet once daily, administered 30 minutes before filgrastim and continued for 5 days.
Diosmin-Hesperidin Group: Diosmin-Hesperidin 500mg tablet twice daily, administered 30 minutes before filgrastim and continued for 5 days.
Combination Group: Loratadine 10mg tablet once daily plus Diosmin-Hesperidin 500mg tablet twice daily, administered 30 minutes before filgrastim and continued for 5 days.
Filgrastim will be administered according to standard clinical practice for the underlying hematological condition.
Assessments:
Baseline 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.
Follow-up Assessments:
Within 24 hours of the first filgrastim dose, pain will be assessed using the BPI, and baseline TNF-alpha levels will be measured.
After 5 days of treatment, follow-up laboratory tests (including TNF-alpha levels) and pain assessment using the BPI will be conducted.
Primary Outcome:
The 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.
Secondary Outcome:
The secondary outcome is to identify risk factors associated with the frequency and severity of G-CSF-induced bone pain.
Statistical Analysis:
Data 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.
Ethical Considerations:
The 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
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).
No interventions assigned to this group
Intervention
Participants in this arm will receive loratadine 10mg tablets once daily, 30 minutes before filgrastim administration, for 5 days.
Loratadine
Loratadine 10 mg oral tablet administered once daily, starting 30 minutes before filgrastim administration and continued for 5 consecutive days.
Diosmin-Hesperidin
Participants in this arm will receive diosmin-hesperidin 500mg tablets twice daily, 30 minutes before filgrastim administration, for 5 days.
Diosmin-Hesperidin
Diosmin-Hesperidin 500 mg oral tablet administered twice daily, starting 30 minutes before daily filgrastim administration and continued for 5 consecutive days.
Loratadine + Diosmin-Hesperidin
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.
Loratadine + Diosmin-Hesperidin
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.
Interventions
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Loratadine
Loratadine 10 mg oral tablet administered once daily, starting 30 minutes before filgrastim administration and continued for 5 consecutive days.
Diosmin-Hesperidin
Diosmin-Hesperidin 500 mg oral tablet administered twice daily, starting 30 minutes before daily filgrastim administration and continued for 5 consecutive days.
Loratadine + Diosmin-Hesperidin
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.
Eligibility Criteria
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Inclusion Criteria
* Receiving a G-CSF for one of the following indications:
Treatment of neutropenia along with treatment for leukemia or lymphoma Neutropenia prevention following autologous hematopoietic cell transplant
* Patients with or without bone pain associated with G-CSF administration.
* Willingness to provide informed consent to participate in the study.
Exclusion Criteria
* Pregnant or breastfeeding women.
* Patients with known allergies or hypersensitivity to Loratadine, Diosmin- Hespiridin or Filgrastim.
* Patients with pre-existing bone disorders or receiving bone modifying agents
* Chronic use of antihistamines, Diosmin-Hespiridin, NSAIDs, corticosteroids, or immunosuppressants.
* Receiving medications with drug interaction grade X with Loratadine, Diosmin-Hespiridin or Filgrastim
* Patients who are unable to understand or provide informed consent
18 Years
65 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Principal Investigators
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Mai Moustafa Helmy, Professor
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Omar Mohamed Ghallab, Professor
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Reham AbdelHalem Abo Elwafa, Professor
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Noha Alaa Eldin Hamdy, Assistant professor
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Mayssaa Mohamed Elsayed, pharmD
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Locations
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Alexandria University Hospitals
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Mayssaa Mohamed Elsayed
Role: primary
Other Identifiers
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Serial Number: 0108746
Identifier Type: OTHER
Identifier Source: secondary_id
FWA Number: 00018699
Identifier Type: OTHER
Identifier Source: secondary_id
IRB NO:00012098
Identifier Type: -
Identifier Source: org_study_id