NCT07733817Not yet recruiting
Impact of Probiotics on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer.
Impact of Probiotic Supplementation on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer: a Phase III Randomized Study
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 24 Jul 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Apr 2030
- Lead sponsor
- Centre Francois Baclesse
- Diseases
- Colorectal cancer
- NCT number
- NCT07733817
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 1 Oct 2026 to the primary completion date, 1 Apr 2030
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ch Aunay-Bayeux Coordinator of this site? Confirm its status | Bayeux | France | Unknown status |
| CHU Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CH Coordinator of this site? Confirm its status | Saint-Lô | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.