Evaluation of The Effect of Loratadine Versus Diosmin/Hesperidin Combination on Vinca Alkaloids Induced Neuropathy
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 主要终点
- Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on neuropathy pain intensity of Vinca alkaloids neuropathy compared to routine practice.
研究概览
简要总结
All vinca alkaloids causes neuropathy. The incidence of peripheral neuropathy is 30 %-40 % in patients treated with vincristine. The incidence of long term neurological adverse events from vinblastine ranged from 50% to 97%. In this study, the investigators will study the effect of using either loratadine or diosmin 450mg/ hesperidin 50 mg combination on neuropathy caused by Vinca alkaloids therapy. This study is a prospective, controlled, randomized, interventional and open-label clinical trial.
详细描述
Ninety patients will be randomly assigned to three groups as follows:
Group 1 (Control group): 30 patients will receive Vincristine 1.5 mg/m2 (maximum: 2 mg) or Vinblastine 6 mg/m2 according to treatment protocol.
Group 2 (Loratadine group): 30 patients will receive One tablet 10 mg orally once daily starting with vincristine or vinblastine administration for three cycles.
Group 3 (hesperidin 50 mg/diosmin 450mg group): 30 patients will receive 50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet orally twice daily starting with vincristine or vinblastine administration for three cycles .
Vincristine or Vinblastine dose will be adjusted as follows: Serum bilirubin 1.5 to 3 mg/dL or transaminases 2 to 3 times ULN or alkaline phosphatase increased: Administer 50% of dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients prescribed vincristine or vinblastine according to standard protocols.
- •Adult patients older than18 years.
- •Patients willing to participate in the study and sign the informed consent.
- •Adequate bone barrow function (platelet count> 150 *103per microliter, absolute neutrophil count> 500 per microliter)
- •Eastern cooperative oncology group (ECOG) performance status Grade 0-2
排除标准
- •Hypersensitivity or contraindication to loratadine, hesperidin or diosmin combination or any component of the formulation.
- •Pre-existence or history of peripheral neuropathy due to a cause different from Vinca alkaloids induced neuropathy.
- •Receiving any other medication known to cause neuropathy.
- •Receiving medications with drug interaction grade X with Loratadine as Thalidomide, Tiotropium or Orphenadrine.
- •Women of childbearing potential not using an effective contraceptive method.
- •Pregnancy or breastfeeding.
- •Inability to understand patients' information and informed consent form.
- •Severe hepatic impairment.
研究组 & 干预措施
Loratadine group
30 patients will receive One tablet 10 mg orally once daily starting with vincristine or vinblastine administration for three cycles
干预措施: Loratadine (Drug)
diosmin 450mg / hesperidin 50 mg group
30 patients will receive 50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet orally twice daily starting with vincristine or vinblastine administration for three cycles
干预措施: Diosmin/ Hesperidin (Drug)
结局指标
主要结局
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on neuropathy pain intensity of Vinca alkaloids neuropathy compared to routine practice.
时间窗: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Measure of average pain intensity assessed by Numeric Pain Rating Scale (NS) change from baseline to after three cycles of vinca alkaloids therapy
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on pain quality (i.e. sensory and pain) of Vinca alkaloids neuropathy compared to routine practice.
时间窗: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Neuropathic Pain in 4 questions (DN4) change from baseline to after three cycles of vinca alkaloids therapy
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on symptoms of peripheral neuropathy of Vinca alkaloids compared to routine practice.
时间窗: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) change from baseline to after three cycles of vinca alkaloids therapy
Assessing the efficacy of loratadine or diosmin 450mg/ hesperidin 50 mg on development of Vinca alkaloids neuropathy compared to routine practice.
时间窗: At baseline and after three cycles of vinca alkaloids (each cycle is 28 days)
Measuring Peripheral blood Neurofilament Proteins and IL-1 beta change from baseline to after three cycles of vinca alkaloids therapy
次要结局
- Evaluating the effect of loratadine versus diosmin 450mg/hesperidin 50 mg on the time to onset of neuropathy caused by Vinca alkaloids compared to control group.(from baseline to after Three cycles of vinca alkaloids (each cycle is 28 days))
- Evaluating the Number of participants with Adverse Events of loratadine versus hesperidin 50 mg/diosmin 450mg by monitoring patients for undesirable effects(from baseline to after Three cycles of vinca alkaloids (each cycle is 28 days))
研究者
Noha Kamal Morsy Ibraheem
Assistant lecturer at faculty of Pharmacy, University of Sadat City
Ain Shams University