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

Официальное название

A Comparative Study of Diosmin-Hesperidin and Loratadine for the Prevention of G-CSF Induced Bone Pain in Patients With Hematological Malignancies

Обзор

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?

Подробное описание

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.

Вмешательства

• Препарат Loratadine
  Loratadine 10 mg oral tablet administered once daily, starting 30 minutes before filgrastim administration and continued for 5 consecutive days.
• Препарат Diosmin-Hesperidin
  Diosmin-Hesperidin 500 mg oral tablet administered twice daily, starting 30 minutes before daily filgrastim administration and continued for 5 consecutive days.
• Препарат 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.

Первичные конечные точки

• Bone Pain Severity (Brief Pain Inventory) [Срок оценки: Baseline (before first dose of Filgrastim), 24 hours after first Filgrastim dose, and 5 days after treatment initiation.]
• Bone Pain Interference (Brief Pain Inventory) [Срок оценки: 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 [Срок оценки: 24 hours after first Filgrastim dose, and After 5 days of the intervention period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Египет · 1 центр

• Alexandria University Hospitals — Alexandria

Идентификаторы

NCT: NCT07300735 · IRB NO:00012098 · Serial Number: 0108746 · FWA Number: 00018699

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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