RecruitingNot ApplicableNCT07300735

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

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


Sponsor

Alexandria University

Enrollment

88 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria7

  • Patients with solid tumors.
  • 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

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Interventions

DRUGLoratadine

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

DRUGDiosmin-Hesperidin

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

DRUGLoratadine + 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.


Locations(1)

Alexandria University Hospitals

Alexandria, Egypt

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NCT07300735


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