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A Comparative Study of Diosmin-Hesperidin and Loratadine for the Prevention of G-CSF Induced Bone Pain in Patients With Hematological Malignancies

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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. 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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Adults 18 to 65 years old

• 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.

Locations
Other Locations
Egypt
Alexandria University Hospitals
RECRUITING
Alexandria
Contact Information
Primary
Mayssaa Mohamed Elsayed, M.S. Candidate
Maya_salam2007@yahoo.com
+201097973834
Backup
Noha AlaaEldine Hamdy, Assistant professor
Noha.alaaeldine@alexu.edu.eg
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 88
Treatments
No_intervention: 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).
Active_comparator: Intervention
Participants in this arm will receive loratadine 10mg tablets once daily, 30 minutes before filgrastim administration, for 5 days.
Experimental: Diosmin-Hesperidin
Participants in this arm will receive diosmin-hesperidin 500mg tablets twice daily, 30 minutes before filgrastim administration, for 5 days.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Alexandria University

This content was sourced from clinicaltrials.gov