Adult Clinical Trial
Official title:
Evaluation of Intensity and Consequences of Neuropathic Disorders Induced by Oxaliplatin in Patients After Chemotherapy: Observational and Cross-sectional Study
This project will evaluate the neurotoxic effects of oxaliplatin. Oxaliplatin is considered
the most neurotoxic chemotherapy, and at the origin of peripheral neuropathies. These
neuropathies remain a problem in oncology because currently no prevention strategy has proved
effective and only duloxetine seems to have a therapeutic benefit in improving symptoms. In
the case of oxaliplatin, neuropathy forced oncologists to reduce the dose or to stop the
chemotherapy, potentially degrading the oncological prognosis.
Objective of this study will be to assess, on a large number of patients (n> 500) who
completed adjuvant chemotherapy (FOLFOX), the intensity of neuropathic disorders out of 5
years after the end of chemotherapy. Furthermore, this study should enable an assessment of
the relationship between the intensity of neuropathy and comorbidities, such as anxiety and
depression and health related quality of life of patients.
Oxaliplatin remains the reference treatment of advanced colorectal cancer and more broadly of
digestive cancers, incorporated in the FOLFOX protocol (folinic acid, 5-Fu, Oxaliplatin). But
oxaliplatin chemotherapy is certainly the most neurotoxic, as on average 90% of patients
develop acute neuropathic disorders (within hours or days of the infusion) and 30% to 50% of
patients develop a chronic neuropathy with repeated cycles of chemotherapy. The neuropathic
grade and duration of symptoms remain variable across studies. Although symptoms improve with
time, long-term studies suggest a persistent neuropathy beyond 24 months. Moreover,
Vatandoust and colleagues suggest that chemotherapy-induced neuropathy is more frequent and
severe over the long term (≥ 12 months) than in previous works published.
In cancer survivors, neuropathy induced by oxaliplatin has a deleterious impact on their
quality of life. But, few studies are available on the consequences of oxaliplatin-induced
neuropathy in these patients, while these patients remain, in 2003, the third largest group
of cancer survivors.
Only 7 studies have specifically evaluated neuropathic disorders induced by oxaliplatin after
chemotherapy. Moreover, as pointed Vatandoust and colleagues, there is a real need to
understand the long term effects of this chemotherapy-induced neuropathy. More specifically,
only two studies have evaluated the effects of neuropathy on quality of life and
comorbidities of patients.
Objective of this study will be to assess, on a large number of patients (n> 500) who
completed adjuvant chemotherapy (FOLFOX), the intensity of neuropathic disorders out of 5
years after the end of chemotherapy. Furthermore, this study should enable an assessment of
the relationship between the intensity of neuropathy and comorbidities, such as anxiety and
depression and health related quality of life of patients.
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