Long Term Effect of Oxaliplatin Treatment in Cancer Survivors (PREVOX)

September 14, 2020 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

409

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU clermont-ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

colorectal cancer survivors

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
colorectal cancer survivors
Drug: Oxaliplatin
Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).
Time Frame: once and until 5 years after the end of chemotherapy
once and until 5 years after the end of chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Thermal hypersensitivity to cold and hot assessed by VAS.
Time Frame: once and until 5 years after the end of chemotherapy
once and until 5 years after the end of chemotherapy
Neuropathic pain evaluated by the DN4 interview questionnaire.
Time Frame: once and until 5 years after the end of chemotherapy
once and until 5 years after the end of chemotherapy
Anxiety and depression assessed by HADS questionnaire.
Time Frame: once and until 5 years after the end of chemotherapy
once and until 5 years after the end of chemotherapy
Health related quality of life assessed by QLQ-C30 questionnaire (EORTC).
Time Frame: once and until 5 years after the end of chemotherapy
once and until 5 years after the end of chemotherapy
Grade of neuropathy during chemotherapy (NCI-CTCAE).
Time Frame: once and until 5 years after the end of chemotherapy
once and until 5 years after the end of chemotherapy
Cumulative dose (mg / m²) and dose intensity (mg / m² / week) of oxaliplatin
Time Frame: once and until 5 years after the end of chemotherapy
once and until 5 years after the end of chemotherapy
pain assessed by visual analog scale (VAS).
Time Frame: once and until 5 years after the end of chemotherapy
once and until 5 years after the end of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Denis PEZET, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

August 29, 2019

Study Completion (Actual)

August 29, 2019

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0290

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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