NCT02970526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
409

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
Last Updated

September 16, 2020

Status Verified

January 1, 2019

Enrollment Period

3.2 years

First QC Date

November 18, 2016

Last Update Submit

September 14, 2020

Conditions

Colorectal Cancer SurvivorsOxaliplatin RegimenAdult

Keywords

Colorectal cancer survivors

Outcome Measures

Primary Outcomes (1)

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

    once and until 5 years after the end of chemotherapy

Secondary Outcomes (7)

  • Thermal hypersensitivity to cold and hot assessed by VAS.

    once and until 5 years after the end of chemotherapy

  • Neuropathic pain evaluated by the DN4 interview questionnaire.

    once and until 5 years after the end of chemotherapy

  • Anxiety and depression assessed by HADS questionnaire.

    once and until 5 years after the end of chemotherapy

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

    once and until 5 years after the end of chemotherapy

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

    once and until 5 years after the end of chemotherapy

  • +2 more secondary outcomes

Study Arms (1)

colorectal cancer survivors

Drug: Oxaliplatin

Interventions

OxaliplatinDRUG

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

colorectal cancer survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

colorectal cancer survivors

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

  • 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.

    PMID: 32727095BACKGROUND

  • Balayssac D, Kerckhove N, Selvy M, Pereira B, Gonneau C, 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, Pezet D, Martin V. Motor disorders related to oxaliplatin-induced peripheral neuropathy: long-term severity and impact on quality of life. Support Care Cancer. 2024 Jun 13;32(7):427. doi: 10.1007/s00520-024-08627-8.

    PMID: 38869647DERIVED

MeSH Terms

Interventions

Oxaliplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Denis PEZET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 22, 2016

Study Start

July 1, 2016

Primary Completion

August 29, 2019

Study Completion

August 29, 2019

Last Updated

September 16, 2020

Record last verified: 2019-01

Locations

FR(1)