Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlexandria University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults 18 to 65 years old
Patients with or without bone pain associated with G-CSF administration.
Willingness to provide informed consent to participate in the study.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Loratadine
DrugLoratadine 10 mg oral tablet administered once daily, starting 30 minutes before filgrastim administration and continued for 5 consecutive days.
Diosmin-Hesperidin
DrugDiosmin-Hesperidin 500 mg oral tablet administered twice daily, starting 30 minutes before daily filgrastim administration and continued for 5 consecutive days.
Loratadine + Diosmin-Hesperidin
DrugCombination 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.
Treatment groups
88 Participants
are divided into 4 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionActive comparator 1 intervention
Group C: Diosmin-HesperidinExperimental treatment 1 intervention
Group D: Loratadine + Diosmin-HesperidinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline (before first dose of Filgrastim), 24 hours after first Filgrastim dose, and 5 days after treatment initiation.2
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).
Time frame
Baseline (before first dose of Filgrastim), 24 hours after first Filgrastim dose, and 5 days after treatment initiation.3
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.
Time frame
24 hours after first Filgrastim dose, and After 5 days of the intervention periodSponsors and contacts
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Source ClinicalTrials.gov