Chemotherapy Induced Peripheral Neurotoxicity (CIPN): Why Should we Care
ConditionCIPN
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Milano Bicocca
About this trial
This is a pilot, observational, cross-sectional, study on socio-economic burden related to chemotherapy-induced peripheral neurotoxicity (CIPN). Investigators will collect CIPN healthcare related costs on a detailed clinical patient-level. As a sub-study, data obtained in this cross-sectional study, will be compared with administrative larger datasets on patients affected by cancer. The aim is to run a test for potential proxy variables which are available in larger administrative datasets, even if not directly measuring CIPN, to learn more about the impact of CIPN.
Eligibility criteria
Qualifiers
at least 75 consecutive subjects sent for a neurological evaluation before 1st chemotherapy cycle (TNSc score equal to 0 which means no neuropathy);
at least 75 consecutive subjects sent for a neurological evaluation due to stable CIPN condition (CIPN defined as TNSc > or = 1) after chemotherapy completion (at least 2 months off treatment).
Male and female subjects who are 18 years of age or older.
Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.
Disqualifiers
Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
Severe depression that in the opinion of the Investigator would complicate the assessments.
Subjects who are currently receiving another medication other than antineoplastic chemotherapy drugs that has known potential to produce neurologic peripheral nerve toxicity (e.g., metronidazole, isoniazid, amiodarone, antiretroviral medications).
Subjects who suffer from another medical condition that can cause neuropathy (e.g., diabetes)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov