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

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ClinicalTrials.gov Identifier: NCT02970526
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment
Colorectal Cancer Survivors Oxaliplatin Regimen Adult Drug: Oxaliplatin

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.


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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of Intensity and Consequences of Neuropathic Disorders Induced by Oxaliplatin in Patients After Chemotherapy: Observational and Cross-sectional Study
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Group/Cohort Intervention/treatment
colorectal cancer survivors Drug: Oxaliplatin
Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
colorectal cancer survivors
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970526


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    0473751195    placarin@chu-clermontferrand.fr   
Principal Investigator: Denis PEZET         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Denis PEZET University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02970526     History of Changes
Other Study ID Numbers: CHU-0290
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Keywords provided by University Hospital, Clermont-Ferrand:
Colorectal cancer survivors
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents