Hematologic MalignancyNCT07300735
Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood Cancers
A study testing Loratadine, Diosmin-Hesperidin and Loratadine + Diosmin-Hesperidin in people with Hematologic Malignancy and Neutropenia, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematologic Malignancy, Neutropenia, Bone Pain
- What is being tested?
- Loratadine, Diosmin-Hesperidin and Loratadine + Diosmin-Hesperidin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Noha AlaaEldine Hamdy, Assistant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University Hospitals
Alexandria, 21532
Mayssaa Mohamed Elsayed, +20 1097973834, Maya_salam2007@yahoo.com
About this study
Official title: A Comparative Study of Diosmin-Hesperidin and Loratadine for the Prevention of G-CSF Induced Bone Pain in Patients With Hematological Malignancies
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:
Read more
- 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?
Read the detailed description
This is a prospective, controlled, randomized, and open-label clinical trial conducted at Alexandria University Hospitals to compare the efficacy of diosmin-hesperidin versus loratadine, and their combination, for the prevention of G-CSF-induced bone pain in adult patients (18-65 years) with hematological malignancies (leukemia or lymphoma) receiving filgrastim.
Rationale:
G-CSF-induced bone pain is a common and debilitating side effect, impacting patient quality of life. While current management strategies using NSAIDs and antihistamines are not always sufficient, diosmin, a flavonoid with known anti-inflammatory and neuroprotective properties, has not been thoroughly investigated for this indication. This study aims to address this gap and explore the potential of diosmin, loratadine, and their combination to mitigate G-CSF-induced bone pain.
Study Design:
Participants meeting the eligibility criteria (detailed elsewhere) will be randomly assigned to one of four treatment groups:
Control Group: No specific treatment for bone pain. Loratadine Group: Loratadine 10mg tablet once daily, administered 30 minutes before filgrastim and continued for 5 days.
Diosmin-Hesperidin Group: Diosmin-Hesperidin 500mg tablet twice daily, administered 30 minutes before filgrastim and continued for 5 days.
Combination Group: Loratadine 10mg tablet once daily plus Diosmin-Hesperidin 500mg tablet twice daily, administered 30 minutes before filgrastim and continued for 5 days.
Filgrastim will be administered according to standard clinical practice for the underlying hematological condition.
Assessments:
Baseline Assessment: Before the start of filgrastim administration, demographic data, medical history (including type of malignancy, comorbidities, prior G-CSF treatment, and chemotherapy details), baseline laboratory tests (CBC, CRP, liver and kidney function), and baseline pain assessment using the Brief Pain Inventory (BPI) will be collected.
Follow-up Assessments:
Within 24 hours of the first filgrastim dose, pain will be assessed using the BPI, and baseline TNF-alpha levels will be measured.
After 5 days of treatment, follow-up laboratory tests (including TNF-alpha levels) and pain assessment using the BPI will be conducted.
Primary Outcome:
The primary outcome is to compare the effectiveness of diosmin-hesperidin, loratadine, and their combination in preventing G-CSF-induced bone pain. This will be assessed by changes in pain frequency and severity (measured by the BPI) and changes in serum TNF-alpha levels.
Secondary Outcome:
The secondary outcome is to identify risk factors associated with the frequency and severity of G-CSF-induced bone pain.
Statistical Analysis:
Data will be analyzed using IBM SPSS version 26. Appropriate statistical tests will be used to compare the treatment groups and assess the relationships between variables.
Ethical Considerations:
The study will be conducted in accordance with the Declaration of Helsinki and will be subject to approval by the Ethics Committee of Alexandria University. All participants will provide written informed consent before enrollment.
- Conditions
- Hematologic Malignancy, Neutropenia, Bone Pain
- Being tested
- Loratadine, Diosmin-Hesperidin, Loratadine + Diosmin-Hesperidin
- Keywords
- Loratadine, Diosmin, Filgrastim, Granulocyte Colony Stimulating Factor, G-CSF Induced Bone Pain, Hesperidin, Flavonoid, Antihistamine, Prophylaxis, Randomized Controlled Trial
- Medical subject headings
- Hematologic Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoratadineDrug
Loratadine 10 mg oral tablet administered once daily, starting 30 minutes before filgrastim administration and continued for 5 consecutive days.
Diosmin-HesperidinDrug
Diosmin-Hesperidin 500 mg oral tablet administered twice daily, starting 30 minutes before daily filgrastim administration and continued for 5 consecutive days.
Loratadine + Diosmin-HesperidinDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Loratadine + Diosmin-Hesperidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 24 hours after first Filgrastim dose, and After 5 days of the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai Moustafa Helmy, Professor, Principal investigator, Alexandria UniversityOmar Mohamed Ghallab, Professor, Principal investigator, Alexandria UniversityReham AbdelHalem Abo Elwafa, Professor, Principal investigator, Alexandria UniversityNoha Alaa Eldin Hamdy, Assistant professor, Principal investigator, Alexandria UniversityMayssaa Mohamed Elsayed, pharmD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300735
- Sponsor's protocol ID
- IRB NO:00012098
- Other IDs
- Serial Number: 0108746, FWA Number: 00018699
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Diosmin-Hesperidin and Loratadine for the Prevention of G-CSF Induced Bone Pain in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07300735
- Acronym / sponsor ID
- IRB NO:00012098
- Conditions
- Hematologic Malignancy, Neutropenia, Bone Pain
- Keywords
- Loratadine, Diosmin, Filgrastim, Granulocyte Colony Stimulating Factor, G-CSF Induced Bone Pain, Hesperidin, Flavonoid, Antihistamine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
This is a prospective, controlled, randomized, and open-label clinical trial conducted at Alexandria University Hospitals to compare the efficacy of diosmin-hesperidin versus loratadine, and their combination, for the prevention of G-CSF-induced bone pain in adult patients (18-65 years) with hematological malignancies (leukemia or lymphoma) receiving filgrastim.
Rationale:
G-CSF-induced bone pain is a common and debilitating side effect, impacting patient quality of life. While current management strategies using NSAIDs and antihistamines are not always sufficient, diosmin, a flavonoid with known anti-inflammatory and neuroprotective properties, has not been thoroughly investigated for this indication. This study aims to address this gap and explore the potential of diosmin, loratadine, and their combination to mitigate G-CSF-induced bone pain.
Study Design:
Participants meeting the eligibility criteria (detailed elsewhere) will be randomly assigned to one of four treatment groups:
Control Group: No specific treatment for bone pain. Loratadine Group: Loratadine 10mg tablet once daily, administered 30 minutes before filgrastim and continued for 5 days.
Diosmin-Hesperidin Group: Diosmin-Hesperidin 500mg tablet twice daily, administered 30 minutes before filgrastim and continued for 5 days.
Combination Group: Loratadine 10mg tablet once daily plus Diosmin-Hesperidin 500mg tablet twice daily, administered 30 minutes before filgrastim and continued for 5 days.
Filgrastim will be administered according to standard clinical practice for the underlying hematological condition.
Assessments:
Baseline Assessment: Before the start of filgrastim administration, demographic data, medical history (including type of malignancy, comorbidities, prior G-CSF treatment, and chemotherapy details), baseline laboratory tests (CBC, CRP, liver and kidney function), and baseline pain assessment using the Brief Pain Inventory (BPI) will be collected.
Follow-up Assessments:
Within 24 hours of the first filgrastim dose, pain will be assessed using the BPI, and baseline TNF-alpha levels will be measured.
After 5 days of treatment, follow-up laboratory tests (including TNF-alpha levels) and pain assessment using the BPI will be conducted.
Primary Outcome:
The primary outcome is to compare the effectiveness of diosmin-hesperidin, loratadine, and their combination in preventing G-CSF-induced bone pain. This will be assessed by changes in pain frequency and severity (measured by the BPI) and changes in serum TNF-alpha levels.
Secondary Outcome:
The secondary outcome is to identify risk factors associated with the frequency and severity of G-CSF-induced bone pain.
Statistical Analysis:
Data will be analyzed using IBM SPSS version 26. Appropriate statistical tests will be used to compare the treatment groups and assess the relationships between variables.
Ethical Considerations:
The study will be conducted in accordance with the Declaration of Helsinki and will be subject to approval by the Ethics Committee of Alexandria University. All participants will provide written informed consent before enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: LoratadineParticipants in this arm will receive loratadine 10mg tablets once daily, 30 minutes before filgrastim administration, for 5 days. |
| Diosmin-Hesperidin | Experimental | Drug: Diosmin-HesperidinParticipants in this arm will receive diosmin-hesperidin 500mg tablets twice daily, 30 minutes before filgrastim administration, for 5 days. |
| Loratadine + Diosmin-Hesperidin | Experimental | Drug: Loratadine + Diosmin-HesperidinParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoratadineLoratadine 10 mg oral tablet administered once daily, starting 30 minutes before filgrastim administration and continued for 5 consecutive days. | Drug | Intervention |
| Diosmin-HesperidinDiosmin-Hesperidin 500 mg oral tablet administered twice daily, starting 30 minutes before daily filgrastim administration and continued for 5 consecutive days. | Drug | Diosmin-Hesperidin |
| Loratadine + Diosmin-HesperidinCombination 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. | Drug | Loratadine + Diosmin-Hesperidin |
Primary outcome
Bone Pain Severity (Brief Pain Inventory)
Time frame: 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)
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noha AlaaEldine Hamdy, Assistant professor contact
Mai Moustafa Helmy, Professor principal investigator
Alexandria University
Omar Mohamed Ghallab, Professor principal investigator
Alexandria University
Reham AbdelHalem Abo Elwafa, Professor principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loratadine, Diosmin-Hesperidin and Loratadine + Diosmin-Hesperidin in people with Hematologic Malignancy and Neutropenia, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mayssaa Mohamed Elsayed, M.S. Candidate (+201097973834, Maya_salam2007@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Pain Severity (Brief Pain Inventory) (time frame: Baseline (before first dose of Filgrastim), 24 hours after first Filgrastim dose, and 5 days after treatment initiation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.