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Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood Cancers

NCT07300735 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-12-29

No results posted yet for this study

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?

Conditions

Interventions

DRUG

Loratadine

Loratadine 10 mg oral tablet administered once daily, starting 30 minutes before filgrastim administration and continued for 5 consecutive days.

DRUG

Diosmin-Hesperidin

Diosmin-Hesperidin 500 mg oral tablet administered twice daily, starting 30 minutes before daily filgrastim administration and continued for 5 consecutive days.

DRUG

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.

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Mai Moustafa Helmy, Professor · Alexandria University

  • Omar Mohamed Ghallab, Professor · Alexandria University

  • Reham AbdelHalem Abo Elwafa, Professor · Alexandria University

  • Noha Alaa Eldin Hamdy, Assistant professor · Alexandria University

  • Mayssaa Mohamed Elsayed, pharmD · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-03-31
Completion
2026-07-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300735 on ClinicalTrials.gov