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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02970526
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date November 18, 2016
First Posted Date November 22, 2016
Last Update Posted Date September 16, 2020
Actual Study Start Date July 2016
Actual Primary Completion Date August 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2017)		 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 ]
Original Primary Outcome Measures
 (submitted: November 18, 2016)		 Neuropathic pain assessed by visual analog scale (VAS). [ Time Frame: 5 years after the end of chemotherapy ]
Change History
Current Secondary Outcome Measures
 (submitted: May 11, 2017)
  • Thermal hypersensitivity to cold and hot assessed by VAS. [ Time Frame: 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 ]
  • Anxiety and depression assessed by HADS questionnaire. [ Time Frame: 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 ]
  • Grade of neuropathy during chemotherapy (NCI-CTCAE). [ Time Frame: 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 ]
  • pain assessed by visual analog scale (VAS). [ Time Frame: once and until 5 years after the end of chemotherapy ]
Original Secondary Outcome Measures
 (submitted: November 18, 2016)
  • Thermal hypersensitivity to cold and hot assessed by VAS. [ Time Frame: 5 years after the end of chemotherapy ]
  • Neuropathic pain evaluated by the DN4 interview questionnaire. [ Time Frame: 5 years after the end of chemotherapy ]
  • Anxiety and depression assessed by HADS questionnaire. [ Time Frame: 5 years after the end of chemotherapy ]
  • Health related quality of life assessed by QLQ-C30 questionnaire (EORTC). [ Time Frame: 5 years after the end of chemotherapy ]
  • Grade of neuropathy during chemotherapy (NCI-CTCAE). [ Time Frame: 5 years after the end of chemotherapy ]
  • Cumulative dose (mg / m²) and dose intensity (mg / m² / week) of oxaliplatin [ Time Frame: 5 years after the end of chemotherapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Effect of Oxaliplatin Treatment in Cancer Survivors
Official Title Evaluation of Intensity and Consequences of Neuropathic Disorders Induced by Oxaliplatin in Patients After Chemotherapy: Observational and Cross-sectional Study
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population colorectal cancer survivors
Condition
  • Colorectal Cancer Survivors
  • Oxaliplatin Regimen
  • Adult
Intervention Drug: Oxaliplatin
Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).
Study Groups/Cohorts colorectal cancer survivors
Intervention: Drug: Oxaliplatin
Publications * Selvy M, Pereira B, Kerckhove N, Gonneau C, Feydel G, Pétorin C, Vimal-Baguet A, Melnikov S, Kullab S, Hebbar M, Bouché O, Slimano F, Bourgeois V, Lebrun-Ly V, Thuillier F, Mazard T, Tavan D, Benmammar KE, Monange B, Ramdani M, Péré-Vergé 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). pii: E2400. doi: 10.3390/jcm9082400.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 30, 2020)		 409
Original Estimated Enrollment
 (submitted: November 18, 2016)		 700
Actual Study Completion Date August 29, 2019
Actual Primary Completion Date August 29, 2019   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02970526
Other Study ID Numbers CHU-0290
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor University Hospital, Clermont-Ferrand
Collaborators Not Provided
Investigators
Principal Investigator: Denis PEZET University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date January 2019