Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Bloo… (NCT07300735) | Clinical Trial Compass
RecruitingNot Applicable
Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood Cancers
Egypt88 participantsStarted 2025-03-01
Plain-language 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?
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone Pain Severity (Brief Pain Inventory)
Timeframe: 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)
Timeframe: 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
Timeframe: 24 hours after first Filgrastim dose, and After 5 days of the intervention period