A Comparative Study of Diosmin-Hesperidin and Loratadine for the Prevention of G-CSF Induced Bone Pain in Patients With Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Bone Pain Severity (Brief Pain Inventory)
研究概览
简要总结
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?
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention
Participants in this arm will receive loratadine 10mg tablets once daily, 30 minutes before filgrastim administration, for 5 days.
干预措施: Loratadine (Drug)
Diosmin-Hesperidin
Participants in this arm will receive diosmin-hesperidin 500mg tablets twice daily, 30 minutes before filgrastim administration, for 5 days.
干预措施: Diosmin-Hesperidin (Drug)
Loratadine + Diosmin-Hesperidin
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.
干预措施: Loratadine + Diosmin-Hesperidin (Drug)
结局指标
主要结局
Bone Pain Severity (Brief Pain Inventory)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点