Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0.
研究概览
简要总结
This study recommends the use of OnLife dietary supplement, which will be followed by a few day before the initiation of PACLITAXEL, for the prevention of PACLITAXEL induced neuropathy. OnLife will be continued one month after stopping chemotherapy.
This would limit the number of PACLITAXEL dose reductions and premature interruptions of this chemotherapy, thus potentially improving the results in terms of antitumor efficacy, while improving the quality of life of patients treated with weekly PACLITAXEL.
详细描述
This study recommends the use of OnLife dietary supplement which will be followed by a few day before the initiation of PACLITAXEL for the prevention of PACLITAXEL induced neuropathy. OnLife will be continued one month after stopping chemotherapy. This would limit the number of PACLITAXEL dose reductions and premature interruptions of this cehemotherapy, thus potentially improving the results in terms of antitumor efficacy while improving the quality of life of patients treated with weekly PACLITAXEL.
Two treatment arms :
- ARM A : 20 patients included in the placebo arm (Standard chemotherapy with PACLITAXEL + placebo dietary supplement) ARM B : 40 patients included in the experimental arm (standard PACLITAXEL chemotherapy + OnLife® food supplement)
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 Months 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patient with neo-adjuvant or adjuvant management, with an indication for weekly PACLITAXEL 80 mg/m² for 12 courses.
- •Age ≥ 18 years
- •Performans Status ≤ 3 according to Karnofsky and life expectancy greater than 6 months
- •For patients of childbearing age, effective contraception while taking Onlife®/placebo.
- •Patient able to swallow OnLife/placebo® tablets easily
- •Patient able and willing to follow all study procedures (including the completion of numerous questionnaires) in accordance with the protocol
- •Patient has understood, signed and dated the consent form
- •Patient affiliated to the social security system
排除标准
- •Patient previously started on PACLITAXEL
- •Known allergy to any of the substances in the study product Onlife®/placebo (fish oil product)
- •Exogenous (Alcoholism)
- •History of peripheral neuropathy at inclusion and/or presence of sensory and/or motor disorders due to other neurological diseases
- •Pregnant or breastfeeding woman
- •Other uncontrolled progressive pathologies
- •Impossible or random follow-up
- •Persons deprived of liberty or under guardianship (including curatorship)
- •Inability to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
研究组 & 干预措施
Placebo
Standard chemotherapy PACLITAXEL + placebo dietary supplement
干预措施: Placebo (Other)
OnLife®
Standard chemotherapy + OnLife® dietary supplement
干预措施: OnLife® (Drug)
结局指标
主要结局
Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0.
时间窗: At 3 months
Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0. during the consultation with the oncologist at 3 months. The AE graded from 1 to 5. Grade 1 is a better and grade 5 is a worst outcome.
次要结局
- Time to onset of grade ≥ 2 neuropathy.(During 1 year)
- Evaluation of Neuropathic pain symptom inventory (NPSI) scores(At 12 weeks, 16 weeks, 6 months and 12 months)
- Number of participants with musculoskeletal and joint pain(At 12 weeks, 16 weeks 6 months and 12 months.)
- The number and rate of women with at least one dose reduction due to peripheral neuropathy.(During 1 year)
- All peripheral neuropathies graded by the oncologist according to CTCAE V5.0(Every 4 weeks for one year)
- Number of toxicities attributable to OnLife® dietary supplement(Every 4 weeks for one year)
- Name of all concomitant treatments administered for neuropathy(At 12 weeks, 16 weeks, 6 months and 12 months.)
- Evaluation of Overall Neuropathy Limitations Scale (ONLS) scores(At 12 weeks, 16 weeks, 6 months and 12 months)
- The number and rate of women with at least one discontinuation of PACLITAXEL due to peripheral neuropathy.(During 1 year)
- Compliance with the Onlife®/Placebo dietary supplement(16 weeks)
- Quality of life of participants(At baseline and then every 4 weeks for 4 months and then at 6 and 12 months.)