Preventing G-CSF bone pain with diosmin-hesperidin and loratadine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, open-label comparison at Alexandria University Hospitals of four groups: no specific preventive treatment, loratadine, diosmin-hesperidin, and the combination. Adults 18–65 with leukemia or lymphoma receiving filgrastim for neutropenia treatment or autologous transplant prophylaxis will be enrolled and randomized. Treatments are given 30 minutes before filgrastim and continued for five days (loratadine 10 mg once daily; diosmin-hesperidin 500 mg twice daily; or both). The study measures occurrence and severity of G-CSF–related bone pain during the treatment period and compares outcomes across groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Alexandria University Hospitals
  Alexandria, Egypt Recruiting

Study contacts

• Principal investigator: Mai Moustafa Helmy, Professor — Alexandria University
• Study coordinator: Mayssaa Mohamed Elsayed, M.S. Candidate
• Email: Maya_salam2007@yahoo.com
• Phone: +201097973834

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.