Clinical trial · Interventional
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
NCT07733817CI-TRIAL-00119931PROBIOCOLnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenocarcinoma | Colon Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuropathic Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PLACEBO supplementation | Dietary Supplement | — | UNRESOLVED |
| PROBIOTIC SUPPLEMENTATION BY OXXYSLAB® | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Multi-strain PROBIOTIC treatment
- interventionNames
- Dietary Supplement: PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- PLACEBO treatment
- interventionNames
- Dietary Supplement: PLACEBO supplementation
Primary outcomes (1)
- measure
- Proportion of patients who experience a grade ≥2 peripheral neuropathy
- timeFrame
- Around week 12 (+/- 7 days) after initiation of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.