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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Loratadine + 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.

Study 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

Primary outcome measure(s)

• Bone Pain Severity (Brief Pain Inventory) — Baseline (before first dose of Filgrastim), 24 hours after first Filgrastim dose, and 5 days after treatment initiation.
  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).
• Bone Pain Interference (Brief Pain Inventory) — Baseline (before first dose of Filgrastim), 24 hours after first Filgrastim dose, and 5 days after treatment initiation.
  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).
• Change in Serum Tumor Necrosis Factor-alpha (TNF-alpha) Levels — 24 hours after first Filgrastim dose, and After 5 days of the intervention period
  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.

Trial sites (1)

On this site

More Alexandria University trials in Egypt