Protocol Comparing a Nutraceutical Formulation Consisting of Omega-3 Fatty Acids, Vitamin D, and Vitamins B6 Plus B12 Versus No Treatment in the Prevention or Reduction of Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Chemotherapy Induced Peripheral Neuropathy Assessment
研究概览
简要总结
The trial will utilize Nutraceuticals (Vitamin D 2000IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day) in patients treated with Docetacel as Neoadjuvant or Adjuvant Breast cancer Therapy. The trial is being conducted to see if the use of Nutraceuticals will prevent or reduce Chemotherapy Induced Peripheral Neuropathy (CIPN).
详细描述
Phase 2, Single Centre, Open-label 2 Arm Randomized Trial. The intervention group will receive a daily dose of Vitamin D, Omega-3-fatty acids, Vitamin B6, and Vitamin B12. The reference group will have usual care.
Dose of Nutraceuticals: Vitamin D 2000 IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)
Population: Breast Cancer patients undergoing either neoadjuvant or adjuvant therapy with docetaxel.
106 participants in total will be needed with accrual being completed in hopefully 1 years' time. Study Investigators will screen the candidates for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female 18-70 years of age
- •Biopsy proven invasive breast carcinoma
- •Scheduled to receive docetaxel (3-6 cycles)
- •Have values for liver (AST, ALT, Bilirubin) and renal function (CREAT), within 1.5 times normal values as drawn per standard of care.
- •Be able to provide informed consent
- •Willingness to adhere to regimen
排除标准
- •Metastatic disease
- •Any peripheral neuropathy
- •Known HIV (testing not required)
- •Diseases causing malabsorption i.e.: Inflammatory Bowel Disease, Celiac and Whipple's Disease
- •Patients with seafood allergies
- •Patients on Warfarin or with a documented clinically significant bleeding disorder
结局指标
主要结局
Chemotherapy Induced Peripheral Neuropathy Assessment
时间窗: 12 months
To determine if there is a reduction in either severity or incidence of CIPN in patients treated with docetaxel in the female breast cancer population by using a nutraceutical formulation of the investigators design.
次要结局
- Delay in the onset of grade 1 or decrease in the severity of CIPN(12 months after initiation of chemotherapy)
- Affect of Usage of Nutraceuticals on Response to treatment(24 months)