Colorectal Cancer SurvivorsPREVOXNCT02970526
Long Term Effect of Oxaliplatin Treatment in Cancer Survivors
An observational study of Colorectal Cancer Survivors and Oxaliplatin Regimen, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Survivors, Oxaliplatin Regimen, Adult
- What is being tested?
- Oxaliplatin
- How many people
- 409 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to 29 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: colorectal cancer survivors
Who may be able to join
- • 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
Who cannot join
- • 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Intensity and Consequences of Neuropathic Disorders Induced by Oxaliplatin in Patients After Chemotherapy: Observational and Cross-sectional Study
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.
Read the 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
- Being tested
- Oxaliplatin
- Keywords
- Colorectal cancer survivors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).
| Study group | Role | What they receive |
|---|---|---|
| colorectal cancer survivors | Not described Receives: Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).
Measured: once and until 5 years after the end of chemotherapy
Secondary outcomes (7)
Thermal hypersensitivity to cold and hot assessed by VAS.
Measured: once and until 5 years after the end of chemotherapy
Neuropathic pain evaluated by the DN4 interview questionnaire.
Measured: once and until 5 years after the end of chemotherapy
Anxiety and depression assessed by HADS questionnaire.
Measured: once and until 5 years after the end of chemotherapy
Health related quality of life assessed by QLQ-C30 questionnaire (EORTC).
Measured: once and until 5 years after the end of chemotherapy
Grade of neuropathy during chemotherapy (NCI-CTCAE).
Measured: once and until 5 years after the end of chemotherapy
Cumulative dose (mg / m²) and dose intensity (mg / m² / week) of oxaliplatin
Measured: once and until 5 years after the end of chemotherapy
pain assessed by visual analog scale (VAS).
Measured: once and until 5 years after the end of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startJul 2016
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis PEZET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970526
- Sponsor's protocol ID
- CHU-0290
- Acronym
- PREVOX
- Status last verified
- Jan 2019
- First submitted
- 18 Nov 2016
- Last updated
- 16 Sep 2020
- Results posted
- No
Publications
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.
PubMed 32727095Balayssac 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.
PubMed 38869647
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intensity and Consequences of Neuropathic Disorders Induced by Oxaliplatin in Patients After Chemotherapy: Observational and Cross-sectional Study
- ClinicalTrials.gov ID
- NCT02970526
- Acronym / sponsor ID
- PREVOX / CHU-0290
- Conditions
- Colorectal Cancer Survivors, Oxaliplatin Regimen, Adult
- Keywords
- Colorectal cancer survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal cancer survivors | – | Drug: Oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colorectal cancer survivors
Key inclusion criteria (4 listed)
- • Living patient who received adjuvant chemotherapy (FOLFOX).
Key exclusion criteria (4 listed)
- • Patient unable to understand or respond to questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinIntensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC). | Drug | colorectal cancer survivors |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 32727095Selvy 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.
- Derived from this study: PubMed 38869647Balayssac 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis PEZET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Survivors and Oxaliplatin Regimen, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970526, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.