Impact of Probiotics on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Francois Baclesse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®
Dietary supplementPROBIOTIC 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.
PLACEBO supplementation
Dietary supplementPLACEBO 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.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
Around week 12 (+/- 7 days) after initiation of treatmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: