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

Sponsor
Centre Francois Baclesse
Study ID
NCT07733817
Status
Not Yet Recruiting

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Conditions

  • Colon Adenocarcinoma
  • Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • PLACEBO supplementation — DIETARY_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.

Study Details

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 Dates

First listed
Jul 29, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Apr 1, 2030
Completion
Apr 1, 2036

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental group
    Multi-strain PROBIOTIC treatment
  • Placebo Comparator: Control group
    PLACEBO treatment

Primary Outcome Measure

Proportion of patients who experience a grade ≥2 peripheral neuropathy [ Time Frame: Around week 12 (+/- 7 days) after initiation of treatment ]

Central Contacts

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