Exploration of Circulating microRNAs as Biomarkers of Chemo-induced Peripheral Neuropathy: a Study in Cancer Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

This study aims to find out whether certain molecules in the blood, called microRNAs, are linked to how often and how severely people develop nerve damage from chemotherapy. The investigators will look at patients receiving cancer drugs known to affect the nerves, such as paclitaxel (used for lung cancer) and oxaliplatin (used for colorectal cancer).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient treated for colorectal cancer and scheduled to receive oxaliplatin-based adjuvant chemotherapy for at least 6 cycles, or

Patient treated for lung cancer and scheduled to receive paclitaxel-based chemotherapy for at least 4 cycles.

Disqualifiers

Neurodegenerative disease (e.g., Parkinson's, Alzheimer's, etc.),

History of stroke,

Pre-existing neuropathy (QLQ-CIPN20 sensory score ≥ 15/100),

Pain (NRS ≥ 4/10),

Trial design

Design model

Single group

Treatments tested in this trial

  • Assessment of blood concentrations of microRNAs

    Diagnostic test

    day 1, day 43, and day 155.

  • Chemotherapy-induced peripheral neuropathy (CIPN) - grade

    Other intervention

    day 1, day 43, and day 155.

  • Pain assessement

    Other intervention

    day 1, day 43, and day 155.

  • Assessment of blood concentrations of neurofilament light chain

    Diagnostic test

    day 1, day 43, and day 155.

  • Neuropathic pain assessment

    Other intervention

    day 1, day 43, and day 155.

  • Chemotherapy-induced peripheral neuropathy (CIPN) - severity

    Other intervention

    day 1, day 43, and day 155.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Paclitaxel groupExperimental treatment 6 interventions
Group B: Oxaliplatin groupExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Blood concentrations of microRNAs and severity score of sensory chemotherapy-induced peripheral neuropathy

Concentrations of microRNAs will be assessed in plasma, and severity score of sensory chemotherapy-induced peripheral neuropathy will be assessed using the QLQ-CIPN20 questionnaire.

Time frame
day 1, day 43, and day 155

Secondary outcomes

1

Grade of sensory chemotherapy-induced peripheral neuropathy

The grade of sensory chemotherapy-induced peripheral neuropathy will be assessed using the NCI-CTCAE v6.

Time frame
day 1, day 43, and day 155
2

Severity score of motor chemotherapy-induced peripheral neuropathy

The severity score of motor chemotherapy-induced peripheral neuropathy will be assessed using the QLQ-CIPN20 questionnaire

Time frame
day 1, day 43, and day 155
3

Pain occurrence and severity

Pain will be assessed using a numerical rating scale (0-10).

Time frame
day 1, day 43, and day 155
4

Occurrence of neuropathic pain

Neuropathic pain will be assessed in patients reporting pain with a numerical rating scale (NRS) score of 4 or higher out of 10, and a DN4 questionnaire (short form) score of 3 or higher out of 7.

Time frame
day 1, day 43, and day 155

Other outcomes

Sponsors and contacts

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