Cancer, Lung, Colon Neoplasm, Neuropathy;Peripheral
Conditions
Keywords
biomarker, colorectal cancer, lung cancer, oxaliplatin, paclitaxel, chemotherapy-induced peripheral neuropathy
Brief summary
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).
Interventions
DIAGNOSTIC_TESTAssessment of blood concentrations of microRNAs
day 1, day 43, and day 155.
OTHERChemotherapy-induced peripheral neuropathy (CIPN) - grade
day 1, day 43, and day 155.
OTHERPain assessement
day 1, day 43, and day 155.
DIAGNOSTIC_TESTAssessment of blood concentrations of neurofilament light chain
day 1, day 43, and day 155.
OTHERNeuropathic pain assessment
day 1, day 43, and day 155.
OTHERChemotherapy-induced peripheral neuropathy (CIPN) - severity
day 1, day 43, and day 155.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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), * Pregnant or breastfeeding women, * Patients under guardianship, curatorship, deprived of liberty, or under legal protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood concentrations of microRNAs and severity score of sensory chemotherapy-induced peripheral neuropathy | day 1, day 43, and day 155 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade of sensory chemotherapy-induced peripheral neuropathy | day 1, day 43, and day 155 | The grade of sensory chemotherapy-induced peripheral neuropathy will be assessed using the NCI-CTCAE v6. |
| Severity score of motor chemotherapy-induced peripheral neuropathy | day 1, day 43, and day 155 | The severity score of motor chemotherapy-induced peripheral neuropathy will be assessed using the QLQ-CIPN20 questionnaire |
| Pain occurrence and severity | day 1, day 43, and day 155 | Pain will be assessed using a numerical rating scale (0-10). |
| Occurrence of neuropathic pain | day 1, day 43, and day 155 | 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. |
| Concentrations of neurofilament light chain | day 1, day 43, and day 155 | The concentration of neurofilament light chain will be assessed in plasma. |
Countries
France
Contacts
CONTACTLise Laclautre
PRINCIPAL_INVESTIGATORDavid BALAYSSAC
University Hospital, Clermont-Ferrand
Outcome results
None listed