Skip to main content
OpenTrials
Completed

NCT Number: NCT02970526

Long Term Effect of Oxaliplatin Treatment in Cancer Survivors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Oxaliplatin

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Thermal hypersensitivity to cold and hot assessed by VAS.

    Time frame: once and until 5 years after the end of chemotherapy

  2. Neuropathic pain evaluated by the DN4 interview questionnaire.

    Time frame: once and until 5 years after the end of chemotherapy

  3. Anxiety and depression assessed by HADS questionnaire.

    Time frame: once and until 5 years after the end of chemotherapy

  4. Health related quality of life assessed by QLQ-C30 questionnaire (EORTC).

    Time frame: once and until 5 years after the end of chemotherapy

  5. Grade of neuropathy during chemotherapy (NCI-CTCAE).

    Time frame: once and until 5 years after the end of chemotherapy

  6. Cumulative dose (mg / m²) and dose intensity (mg / m² / week) of oxaliplatin

    Time frame: once and until 5 years after the end of chemotherapy

  7. pain assessed by visual analog scale (VAS).

    Time frame: once and until 5 years after the end of chemotherapy

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Evaluation of Intensity and Consequences of Neuropathic Disorders Induced by Oxaliplatin in Patients After Chemotherapy: Observational and Cross-sectional Study

Acronym: PREVOX

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2016
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.