Long Term Effect of Oxaliplatin Treatment in Cancer Survivors

NCT ID: NCT02970526

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 409 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-08-29

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.

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.

Conditions

Colorectal Cancer Survivors; Oxaliplatin Regimen; Adult

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

colorectal cancer survivors

Oxaliplatin

Intervention Type: DRUG

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

Interventions

Oxaliplatin

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis PEZET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 32727095 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38869647 (View on PubMed)

Other Identifiers

CHU-0290

Identifier Type: -

Identifier Source: org_study_id