Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated With Anticancer Drugs

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Georges Francois Leclerc

About this trial

Solid cancers are frequently treated with chemotherapies that target the DNA of cancer cells. It has recently come to light that bacteria are also the target of chemotherapies used in oncology. The results of current studies demonstrate the close link between the composition of the microbiota, the immune system, toxicity and the efficacy or otherwise of anti-cancer treatments.

In this context, the study will measure the influence of treatment with anticancer molecules known to activate the bacterial SOS response on the emergence of antibiotic-resistant commensal bacteria in the gut microbiota of cancer patients. Furthermore, this study will investigate the existence of a close link between changes in the intestinal microbiota determined by the induction or non-induction of the SOS response, bacterial translocation, the integrity of the intestinal barrier and the antitumor immune response.

The RAMA trial plans to collect stool and blood samples from two different cohorts of patients:

* Unexposed cohort: patients receiving anti-cancer treatment that does not induce bacterial SOS response. * Exposed cohort: patients receiving anti-cancer treatment inducing the bacterial SOS response.

Patients' stools will be collected within 7 days of their first chemotherapy treatment and within 7 days of the 3rd chemotherapy cycle. Two blood samples will be taken at the same time as the stool samples.

The results obtained from this prospective clinical research will then be investigated in two experimental laboratory models.

The aim is to demonstrate that cytotoxic anticancer drugs promote the emergence of antibiotic-resistant commensal bacteria, by means of this large-scale study comprising a clinical component, which is the subject of the research presented in this protocol, combined with laboratory research components.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women over 18

Chemotherapy-naive patients.

Squamous cell carcinoma of the upper aerodigestive tract (Non-metastatic, locally advanced, operable or not; Patients receiving concomitant radiochemotherapy using a platinum salt (cisplatin, carboplatin))

Cervical and endometrial cancer (ocally advanced, Non-metastatic; Patients receiving concomitant radiochemotherapy using a platinum salt (cisplatin, carboplatin))

Disqualifiers

Patients unable to collect / send stools for medical, geographical, social or psychological reasons.

Patients who have already received chemotherapy/radiochemotherapy.

Use of anti-infectives for systemic use within 6 months prior to the first sampling, or any other concomitant disease/condition that may influence stool analysis.

Pregnant women and nursing mothers.

Trial design

Design model

Single group

Treatments tested in this trial

  • Mandatory biological samples (blood and sell)

    Other intervention

    At cycle 1 and Cycle 3 : * Stool sample collection * Blood sample collection (5 EDTA tubes)

Treatment groups

260 Participants
are divided into 1 treatment group
Group A: All cohortsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determine whether the digestive microbiota of patients exposed to SOS-inducing cytotoxic cancer drugs favors the emergence of antibiotic-resistant commensal bacteria compared to patients exposed to other non-SOS-inducing cytotoxic cancer drugs.

The primary endpoint is the emergence of antibiotic-resistant Enterobacteriaceae, defined as the presence of Enterobacteriaceae resistant to 3rd-generation cephalosporins and/or fluoroquinolones on the sample taken within 7 days of administration of the 3rd cycle of chemotherapy, compared with the pretreatment initiation sample taken within 7 days of administration of the first cycle of chemotherapy.

Time frame
up to 3 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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