Impact of Probiotics on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer.

Starting soon · Not applicable · Has a placebo group

Conditions studied: Colon Adenocarcinoma, Neuropathic Pain

In brief

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.

Key facts

Study ID

NCT07733817

Run by

Centre Francois Baclesse

People needed

130

Starts

2026-10-01

Expected to finish

2036-04-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Centre François Baclesse — Caen, Centre François Baclesse, France
• Ch Aunay-Bayeux — Bayeux, France
• CHU — Caen, France
• Centre Oscar Lambret — Lille, France
• CHU — Lille, France
• CHU — Rouen, France
• CH — Saint-Lô, France

Full record on ClinicalTrials.gov

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