The Effect of Oral Administration of Hesperidin and Diosmin in Reducing Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- Changes in serum levels of the following biomarker:Nerve growth factor (NGF)
研究概览
简要总结
The aim of this study is evaluation of the potential neuroprotective effect of oral hesperidin and diosmin in reducing paclitaxel- induced peripheral neuropathy in the treatment of breast cancer patients.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients over 18 years of age with pathologically confirmed breast cancer.
- •Breast cancer patients candidate for chemotherapy and will receive paclitaxel.
- •Patients having an eastern cooperative oncology group (ECOG) score more than 2
排除标准
- •Patients with signs and symptoms of clinical neuropathy at baseline.
- •Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
- •Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
- •Patients who have previously received chemotherapy.
- •Hepatic impaired patients.
- •Patient with history of allergy to hesperidin.
- •Patients with history of allergy to diosmin.
- •Renal impaired patients.
- •Patient inadherent to paclitaxel.
- •Patients inadherent to the administered hesperidin and diosmin during the study period.
研究组 & 干预措施
Group 2 (Intervention group): patients which will receive Paclitaxel plus Hespiridin and Diosmin.
patients which will receive Paclitaxel plus Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet) 2 tablets daily, i.e. 1 tablet at midday and 1 tablet in the evening, at meal times.
干预措施: Hespiridin and Diosmin (Drug)
结局指标
主要结局
Changes in serum levels of the following biomarker:Nerve growth factor (NGF)
时间窗: 3 months
Nerve growth factor (NGF) measured in Pg/ml
Changes in serum levels of the following biomarker :Malondialdehyde (MDA).
时间窗: 3 months
Malondialdehyde (MDA) is measured in Micro mole/L
Changes in serum levels of the following biomarker:Interleukin-1 beta (IL-1 β).
时间窗: 3 months
Interleukin-1 beta (IL-1 β) is measured in Pg/ml
Changes in serum levels of the following biomarker: Tumor necrosis Factor-Alpha (TNF- α) .
时间窗: 3 months
Tumor necrosis Factor-Alpha (TNF- α) is measured in Pg/ml
次要结局
- A- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria assessed.(at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).)
- B- Measurement of the quality of life using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire assessed.(at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).)