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

NCT07300735 | Recruiting

• 3 other identifiers: IRB NO:00012098Serial Number: 0108746FWA Number: 00018699
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Hematologic Malignancy; Neutropenia; Bone Pain

Keywords

Loratadine; Diosmin; Filgrastim; Granulocyte Colony Stimulating Factor; G-CSF Induced Bone Pain; Hesperidin; Flavonoid; Antihistamine; Prophylaxis; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• Bone Pain Severity (Brief Pain Inventory)

  This will be measured using the validated Brief Pain Inventory (BPI), which assesses pain intensity (e.g., worst pain, average pain). BPI pain severity will be compared for each trial arm. BPI pain severity will be compared as a composite score (sum of individual pain values divided by 4). A score ranging from 0 (no pain) to 10 (worst pain imaginable).

  Baseline (before first dose of Filgrastim), 24 hours after first Filgrastim dose, and 5 days after treatment initiation.

• Bone Pain Interference (Brief Pain Inventory)

  This will be measured using the validated Brief Pain Inventory (BPI), which assesses the degree to which pain interferes with daily life. BPI pain Interference will be compared for each trial arm. BPI pain interference will be compared as a composite score (sum of individual pain interference values divided by 7). A scale of 0 (does not interfere) to 10 (completely interferes).

  Baseline (before first dose of Filgrastim), 24 hours after first Filgrastim dose, and 5 days after treatment initiation.

• Change in Serum Tumor Necrosis Factor-alpha (TNF-alpha) Levels

  Serum TNF-alpha (pg/mL) is an inflammatory cytokine level measured in the blood that is hypothesized to be elevated in G-CSF induced bone pain. The change from baseline levels will be compared across the four study arms to determine the biological effect of the interventions. Lower levels of TNF-alpha are indicative of a reduction in the inflammatory response.

  24 hours after first Filgrastim dose, and After 5 days of the intervention period

Study Arms (4)

Control

NO INTERVENTION

Participants in this arm will receive standard supportive care for G-CSF-induced bone pain, but will not receive the study interventions (loratadine or diosmin-hesperidin).

Intervention

ACTIVE COMPARATOR

Participants in this arm will receive loratadine 10mg tablets once daily, 30 minutes before filgrastim administration, for 5 days.

Drug: Loratadine

Diosmin-Hesperidin

EXPERIMENTAL

Participants in this arm will receive diosmin-hesperidin 500mg tablets twice daily, 30 minutes before filgrastim administration, for 5 days.

Drug: Diosmin-Hesperidin

Loratadine + Diosmin-Hesperidin

EXPERIMENTAL

Participants in this arm will receive loratadine 10mg tablets once daily plus diosmin-hesperidin 500mg tablets twice daily, 30 minutes before filgrastim administration, for 5 days.

Drug: Loratadine + Diosmin-Hesperidin

Interventions

Loratadine DRUG

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

Intervention

Diosmin-Hesperidin DRUG

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

Diosmin-Hesperidin

Loratadine + Diosmin-Hesperidin DRUG

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.

Loratadine + Diosmin-Hesperidin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Hospitals

Alexandria, 21532, Egypt

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Neutropenia

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Mai Moustafa Helmy, Professor

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Omar Mohamed Ghallab, Professor

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Reham AbdelHalem Abo Elwafa, Professor

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Noha Alaa Eldin Hamdy, Assistant professor

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Mayssaa Mohamed Elsayed, pharmD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayssaa Mohamed Elsayed, M.S. Candidate

CONTACT

+201097973834; Maya_salam2007@yahoo.com

Noha AlaaEldine Hamdy, Assistant professor

CONTACT

Noha.alaaeldine@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel-group, randomized, open-label clinical trial comparing four interventions for the prevention of G-CSF-induced bone pain: no specific treatment (control), loratadine, diosmin-hesperidin, and the combination of loratadine and diosmin-hesperidin. Participants will be randomly assigned to one of the four groups and will receive their assigned treatment for 5 days.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 24, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

EG (1)