NCT07733817尚未招募不适用
Impact of Probiotic Supplementation on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer: a Phase III Randomized Study
Centre Francois Baclesse7 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 7
- 主要终点
- Proportion of patients who experience a grade ≥2 peripheral neuropathy
研究概览
简要总结
The pbjective of this study is to assess the impact of a multi-strain bacteria probiotic OXXYSLAB® on the reduction of oxaliplatin-induced peripheral neuropathy in patients with stage III colon cancer receiving FOLFOX or XELOX regimen in adjuvant treatment, assessed using the oxaliplatin-specific scale of Levi.
详细描述
Patients are randomized (1:1 ratio), between:
- Experimental group: Multi-strain PROBIOTIC treatment (OXXYSLAB®) 1.5 g sachet containing maltose and the OXXYSLAB® multi-strain probiotic formulation (eight different live bacterial strains, 200 billion bacteria).
- Control group: PLACEBO treatment 1.5 g sachet strictly identical to OXXYSLAB®, containing maltose only.
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, Care Provider, Investigator)
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
- •Patient ≥ 18 years
- •Patient with histologically confirmed stage III adenocarcinoma colon cancer with curative resection
- •Patient with an indication to start adjuvant oxaliplatin-based chemotherapy (FOLFOX 4 or XELOX regimen)
- •ECOG performance status score of 0 or 1
- •Patient must consent to allow the collection of fecal and blood samples during study for further ancillary studies
- •Screening laboratory values must meet the following criteria:
- •Neutrophils ≥ 1500/ mm³; Platelets ≥ 100 000/ mm³; Hemoglobin ≥ 9.0 g/dL
- •Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN
- •Serum creatinine ≤ 1.5 x ULN or measured or calculated creatinine ≥ 50 ml/min clearance (CrCl) (using the Cockcroft-Gault formula)
- •Patient with French language comprehension
- •Female subject of childbearing potential must have a negative urine or serum pregnancy test within 7 days before study probiotics supplementation start
- •Patient in reproductive age must be willing to use adequate contraception during study probiotics supplementation
- •Patient affiliated to an appropriate social security system
- •Patient has signed informed consent obtained before to any study specific procedures
- •Enclusion Criteria:
- •Patient with any distant metastasis
- •Patient with current peripheral neuropathy of any grade or ongoing treatment prescribed to prevent or treat peripheral neuropathy
- •Patient with hypersensitivity to any ingredients in the composition of the multi-strain formulation and/or maltose
- •Patient with history of acute pancreatitis
- •Patient seriously immunosuppressed
- •Patient with history of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
- •Patient using of probiotics or antibiotic treatments within one month before inclusion
- •Patient with chronic inflammatory gastro-intestinal disease
- •Patient with uracilemia ≥ 16 ng/ml
- •Patient with QT/QTc > 450 msec for men and > 470 msec for women
- •Patient with active infection requiring systemic therapy
- •Patient with personality disorder or any other known progressive psychiatric pathology
- •Patient with neurological previous history with ongoing symptoms (sequelae of head trauma, stroke, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.)
- •Patient with dependence on alcohol and / or drugs
- •Pregnant or lactating woman
- •Simultaneous participation in another clinical study that may compromise the conduct of this study.
- •Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- •Patient deprived of liberty or placed under the authority of a tutor
排除标准
- 未提供
研究组 & 干预措施
Experimental group
Experimental
Multi-strain PROBIOTIC treatment
干预措施: PROBIOTIC SUPPLEMENTATION BY OXXYSLAB® (Dietary Supplement)
Control group
Placebo Comparator
PLACEBO treatment
干预措施: PLACEBO supplementation (Dietary Supplement)
结局指标
主要结局
Proportion of patients who experience a grade ≥2 peripheral neuropathy
时间窗: Around week 12 (+/- 7 days) after initiation of treatment
Oxaliplatin-specific scale of Levi \[min grade 0 (better)- max Grade 4 (worse)\] after 6 cycles for FOLFOX or 4 cycles for XELOX
次要结局
未报告次要终点
研究者
研究点 (7)
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