Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07300735

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

Led by Alexandria University · Updated on 2025-12-29

88

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the best way to prevent bone pain caused by Granulocyte Colony-Stimulating Factor (G-CSF) in adults with blood cancers such as leukemia or lymphoma. This study compares the effectiveness of two oral medications, diosmin-hesperidin (a flavonoid supplement) and loratadine (an anti-allergy drug), alone and in combination, to reduce this common and painful side effect. The trial seeks to find whether these treatments can better manage G-CSF-induced bone pain and improve patient comfort. Participants will be randomly assigned to one of four groups: a control group receiving no specific pain prevention, a loratadine group taking 10 mg once daily, a diosmin-hesperidin group taking 500 mg twice daily, or a combination group taking both medications. All treatments start 30 minutes before filgrastim administration and continue for five days. Filgrastim is given as part of standard care for the underlying blood condition. This open-label trial is conducted at Alexandria University Hospitals. Before treatment, participants will provide medical history and undergo blood tests and pain assessments. Pain severity and interference will be measured with the Brief Pain Inventory at baseline, 24 hours after the first filgrastim dose, and after five days of treatment. Researchers will also monitor tumor necrosis factor-alpha levels in the blood as a marker of inflammation. The study includes safety evaluations and will analyze data to identify factors influencing bone pain. Participation lasts through the treatment and assessment period, with results guiding future pain management strategies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 to 65 years old
  • Receiving G-CSF for treatment of neutropenia with leukemia or lymphoma, or for neutropenia prevention after autologous hematopoietic cell transplant
  • Patients with or without bone pain related to G-CSF
  • Willing to provide informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Patients with solid tumors
  • Pregnant or breastfeeding women
  • Known allergies or hypersensitivity to Loratadine, Diosmin-Hesperidin, or Filgrastim
  • Pre-existing bone disorders or receiving bone modifying agents
  • Chronic use of antihistamines, Diosmin-Hesperidin, NSAIDs, corticosteroids, or immunosuppressants
  • Receiving medications with drug interaction grade X with study drugs
  • Unable to understand or provide informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 days

Participants receive one of four treatments: loratadine, diosmin-hesperidin, a combination of both, or no specific treatment, to prevent G-CSF-induced bone pain. Treatment is administered for 5 consecutive days starting 30 minutes before filgrastim.

Daily visits or assessments during the 5-day treatment period

Follow-up

Duration - Within 24 hours after first filgrastim dose and after 5 days of treatment

Participants undergo follow-up assessments including pain evaluation and laboratory tests to measure effectiveness of the treatment in preventing bone pain.

2 visits (in-person) for pain assessments and laboratory tests

Trial Site Locations

Total: 1 location

1

Alexandria University Hospitals

Alexandria, Egypt, 21532

Actively Recruiting

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Research Team

M

Mayssaa Mohamed Elsayed, M.S. Candidate

N

Noha AlaaEldine Hamdy, Assistant professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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