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

Alexandria University

Status: Enrolling

Conditions: Bone Pain; Hematologic Malignancy; Neutropenia

Treatments: Drug: Loratadine + Diosmin-Hesperidin; Drug: Diosmin-Hesperidin; Drug: Loratadine

Study type: Interventional

Funder types: Other

Identifiers

NCT07300735

Serial Number: 0108746 (Other Identifier)

IRB NO:00012098

FWA Number: 00018699 (Other Identifier)

Details and patient eligibility

About

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?

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 4 patient groups

Control

No Intervention group

Description:

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 group

Description:

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

Treatment:

Drug: Loratadine

Diosmin-Hesperidin

Experimental group

Description:

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

Treatment:

Drug: Diosmin-Hesperidin

Loratadine + Diosmin-Hesperidin

Experimental group

Description:

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.

Treatment:

Drug: Loratadine + Diosmin-Hesperidin