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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Assessment of blood concentrations of microRNAs
Diagnostic testday 1, day 43, and day 155.
Chemotherapy-induced peripheral neuropathy (CIPN) - grade
Other interventionday 1, day 43, and day 155.
Pain assessement
Other interventionday 1, day 43, and day 155.
Assessment of blood concentrations of neurofilament light chain
Diagnostic testday 1, day 43, and day 155.
Neuropathic pain assessment
Other interventionday 1, day 43, and day 155.
Chemotherapy-induced peripheral neuropathy (CIPN) - severity
Other interventionday 1, day 43, and day 155.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Grade of sensory chemotherapy-induced peripheral neuropathy
The grade of sensory chemotherapy-induced peripheral neuropathy will be assessed using the NCI-CTCAE v6.
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
Pain occurrence and severity
Pain will be assessed using a numerical rating scale (0-10).
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.
Sponsors and contacts
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