NCT07733817

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
116mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2036

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

3.5 years

First QC Date

July 24, 2026

Last Update Submit

July 29, 2026

Conditions

Colon AdenocarcinomaNeuropathic Pain

Keywords

FOLFOXPROBIOTICSXELOX

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who experience a grade ≥2 peripheral neuropathy

    Oxaliplatin-specific scale of Levi \[min grade 0 (better)- max Grade 4 (worse)\] after 6 cycles for FOLFOX or 4 cycles for XELOX

    Around week 12 (+/- 7 days) after initiation of treatment

Study Arms (2)

Experimental group

EXPERIMENTAL

Multi-strain PROBIOTIC treatment

Dietary Supplement: PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®

Control group

PLACEBO COMPARATOR

PLACEBO treatment

Dietary Supplement: PLACEBO supplementation

Interventions

PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®DIETARY_SUPPLEMENT

PROBIOTIC treatment (OXXYSLAB®) starts 1 week before first administration of chemotherapy (XELOX or FOLFOX) and be continued until 1 week after end of the last cycle of chemotherapy. PROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose.

Experimental group
PLACEBO supplementationDIETARY_SUPPLEMENT

PLACEBO supplementation starts 1 week before first administration of chemotherapy (XELOX or FOLFOX) and be continued until 1 week after end of the last cycle of chemotherapy. PROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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:
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre François Baclesse

Caen, Centre François Baclesse, 14076, France

Location

Ch Aunay-Bayeux

Bayeux, France

Location

CHU

Caen, France

Location

Centre Oscar Lambret

Lille, France

Location

CHU

Lille, France

Location

CHU

Rouen, France

Location

CH

Saint-Lô, France

Location

MeSH Terms

Conditions

Colonic NeoplasmsNeuralgia

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mélanie DOS SANTOS, MD

CONTACT

+33231455050m.dossantos@baclesse.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 29, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2036

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations

FR(7)