Clinical trial · Observational
Long Term Effect of Oxaliplatin Treatment in Cancer Survivors
Evaluation of Intensity and Consequences of Neuropathic Disorders Induced by Oxaliplatin in Patients After Chemotherapy: Observational and Cross-sectional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult | — | UNRESOLVED | — |
| Colorectal Cancer Survivors | — | UNRESOLVED | — |
| Oxaliplatin Regimen | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- colorectal cancer survivors
- interventionNames
- Drug: Oxaliplatin
Primary outcomes (1)
- 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 (7)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (2)
- BACKGROUNDSelvy 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 32727095
- DERIVEDBalayssac 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 38869647