A Randomized Controlled Trial of Mammalian Omega 3 With Vitamin D3 in Patients at Risk of Chemotherapy Induced Peripheral Neuropathy.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- percentage of participants with a 50% decreases in Total neuropathy score
研究概览
简要总结
The purpose of this study is to determine whether administration of mammalian Omega 3 FA(fatty acid) with Vitamin D3 supplements would lower or prevent the risk of neuropathy due to chemotherapy.
详细描述
The primary objective of this study is to evaluate the impact of mammalian oil Omega 3 FA with Vitamin D3 supplementation on resolution or prevention of Taxanes or Platinum induced peripheral neuropathy compared with placebo. Patients will be allocated to receive the Omega 3 FA & Vitamin D3 supplements or placebo for 6 months. Approximately 600 patients in total will be enrolled in the 2 study arms. The evaluation of neuropathy will be accomplished by electromyography (EMG), Total neuropathy score(TNS), Brief pain inventory (BFI) and the 11-item FACT/GOG-Ntx, version 4 questionnaire (a subscale validated to assess neuropathy due to chemotherapy). In addition, other validated functional measures such as "Time to button a six hole shirt" and "50 ft walk speed test" will be used to test patients physical limitations imposed by peripheral neuropathy. All our patients will undergo an EMG at their first visit, in 3 months and after 6months. Previously mentioned functional measures will also be completed at the patients' first visit, in 3 months and after 6 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Will be receiving chemotherapy(Platinums and/or Taxanes) in the following 2 weeks.
- •Histologically confirmed diagnosis of cancer
- •ECOG 0 to 2
排除标准
- •Prior chemotherapy treatment
- •Pre-existing peripheral PN due to DM,HIV, alcohol abuse, thyroid dysfunction and hereditary PN associated disorders.
- •Taking any nutritional supplement( fish oil, vitamins and minerals) at least there months before enrollment.
研究组 & 干预措施
Placebo
A ineffective placebo drug with the same taste, route of administration and physical appearance as the study drug (omega 3/Vit D 3) that has received approval by health Canada.
干预措施: placebo (Drug)
Omega 3 FA/Vitamin D3 sublingual
patients will be allocated randomly to receive Sub-lingual Omega 3 FA and Vitamin D3 supplements for 6 months, twice daily ,1/2 tea spoon with instructions to keep it under the tongue for 45 sec.
干预措施: mammalian Omega 3 Fatty acids (Drug)
结局指标
主要结局
percentage of participants with a 50% decreases in Total neuropathy score
时间窗: 3 months
次要结局
未报告次要终点
研究者
Nathaniel Bouganim
Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc
McGill University Health Centre/Research Institute of the McGill University Health Centre