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

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

We will test whether diosmin-hesperidin, loratadine, or both can prevent bone pain from G-CSF in adults with leukemia or lymphoma.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Alexandria University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Alexandria)
• Trial ID: NCT07300735 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–65 with hematologic malignancies (leukemia or lymphoma) receiving filgrastim for neutropenia or post-autologous transplant prevention who can provide informed consent are the intended participants.

Not a fit: Patients with solid tumors, pregnant or breastfeeding women, those with pre-existing bone disorders, or those taking contraindicated medications are unlikely to be eligible or to gain benefit from this protocol.

Why it matters

Potential benefit: If effective, these inexpensive oral medicines could reduce G-CSF‑related bone pain, improving patient comfort and the ability to complete cancer care.

How similar studies have performed: Antihistamines such as loratadine have shown mixed results in prior studies for G-CSF bone pain, while diosmin-hesperidin is a relatively novel option with limited prior clinical data for this indication.

Eligibility criteria

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 this trial is running

Alexandria

• Alexandria University Hospitals — Alexandria, Egypt (RECRUITING)

Study contacts

• Principal investigator: Mai Moustafa Helmy, Professor — Alexandria University
• Study coordinator: Mayssaa Mohamed Elsayed, M.S. Candidate

Conditions: Hematologic Malignancy, Neutropenia, Bone Pain, Loratadine, Diosmin, Filgrastim, Granulocyte Colony Stimulating Factor, G-CSF Induced Bone Pain