Clinical trial NCT02970526: Long Term Effect of Oxaliplatin Treatment in Cancer Survivors
Official title: Evaluation of Intensity and Consequences of Neuropathic Disorders Induced by Oxaliplatin in Patients After Chemotherapy: Observational and Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Survivors
Oxaliplatin Regimen
Adult
Keywords: Colorectal cancer survivors
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colorectal cancer survivors

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* • Living patient who received adjuvant chemotherapy (FOLFOX).

  * Patient in remission.
  * FOLFOX chemotherapy over for 0-5 years.
  * Oral Non-opposition to participation in the study

Exclusion Criteria:

* • Patient unable to understand or respond to questionnaires.

  * Age \<18 years.
  * Neurological diseases (eg Parkinson's disease, stroke, fibromyalgia ...).
  * Legal incapacity (person deprived of liberty or under guardianship).

Primary outcomes:
measure: Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).
timeFrame: once and until 5 years after the end of chemotherapy
Secondary outcomes:
measure: Thermal hypersensitivity to cold and hot assessed by VAS.
timeFrame: once and until 5 years after the end of chemotherapy
measure: Neuropathic pain evaluated by the DN4 interview questionnaire.
timeFrame: once and until 5 years after the end of chemotherapy
measure: Anxiety and depression assessed by HADS questionnaire.
timeFrame: once and until 5 years after the end of chemotherapy
measure: Health related quality of life assessed by QLQ-C30 questionnaire (EORTC).
timeFrame: once and until 5 years after the end of chemotherapy
measure: Grade of neuropathy during chemotherapy (NCI-CTCAE).
timeFrame: once and until 5 years after the end of chemotherapy
measure: Cumulative dose (mg / m²) and dose intensity (mg / m² / week) of oxaliplatin
timeFrame: once and until 5 years after the end of chemotherapy
measure: pain assessed by visual analog scale (VAS).
timeFrame: once and until 5 years after the end of chemotherapy
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Denis PEZET
role: PRINCIPAL_INVESTIGATOR
References:
citation: Selvy M, Pereira B, Kerckhove N, Gonneau C, Feydel G, Petorin C, Vimal-Baguet A, Melnikov S, Kullab S, Hebbar M, Bouche O, Slimano F, Bourgeois V, Lebrun-Ly V, Thuillier F, Mazard T, Tavan D, Benmammar KE, Monange B, Ramdani M, Pere-Verge D, Huet-Penz F, Bedjaoui A, Genty F, Leyronnas C, Busserolles J, Trevis S, Pinon V, Pezet D, Balayssac D. Long-Term Prevalence of Sensory Chemotherapy-Induced Peripheral Neuropathy for 5 Years after Adjuvant FOLFOX Chemotherapy to Treat Colorectal Cancer: A Multicenter Cross-Sectional Study. J Clin Med. 2020 Jul 27;9(8):2400. doi: 10.3390/jcm9082400.