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Long Term Effect of Oxaliplatin Treatment in Cancer Survivors

NCT02970526 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 409

Last updated 2020-09-16

No results posted yet for this study

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.

Conditions

  • Colorectal Cancer Survivors
  • Oxaliplatin Regimen
  • Adult

Interventions

DRUG

Oxaliplatin

Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Denis PEZET · University Hospital, Clermont-Ferrand

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-08-29
Completion
2019-08-29

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02970526 on ClinicalTrials.gov