Chemotherapy-induced Peripheral NeuropathyEVANEURONCT03854864
Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Chemotherapy induced peripheral neuropathy (CIPN) is one of the most deleterious adverse effect of neurotoxic anticancer drugs affecting up to 40% of patients. These neurotoxic anticancer agents include mainly: cisplatin (bronchopulmonary cancers), oxaliplatin (colorectal cancers), paclitaxel (breast cancers and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- survey
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2019to 23 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: oncologist
Who may be able to join
- Oncologist
Who cannot join
- pain physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies: Observational and Cross-sectional Study
Chemotherapy induced peripheral neuropathy (CIPN) is one of the most deleterious adverse effect of neurotoxic anticancer drugs affecting up to 40% of patients. These neurotoxic anticancer agents include mainly: cisplatin (bronchopulmonary cancers), oxaliplatin (colorectal cancers), paclitaxel (breast cancers and bronchopulmonary cancers), docetaxel (breast cancers and bronchopulmonary cancers) and bortezomib (multiple myeloma).
CIPN affects not only the quality of life of patients, it also has a major impact on oncology strategy, forcing oncologists to reduce dose-intensity, to stop an ongoing chemotherapy regimen and to change therapeutic strategies, with a risk of compromising patients' survival.
Read more
There is no real preventive or curative treatment (except duloxetine) for CIPN and it is not known what is the practice of oncologists in France? However, it is essential to know the degree of sensitivity of oncologists to this problem and their practice.
With this study, the investigators propose to assess the current practices of management by oncologists in France in 2019, for any type of practitioners of university hospital, or general hospital, for all type of neurotoxic anticancer drugs.
Read the detailed description
This observational and cross-sectional study will be conducted as a survey using the REDCap software and the response to this survey will be done online, in real time, with an automatic, secure and centralized data collection (CHU Clermont-Ferrand).
French oncologist will be contacted by email thanks to the regional cancer networks. Answer to the survey will be done online.
- Being tested
- survey
- Keywords
- Peripheral Nervous System Diseases, Oncologists
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
to assess the current practices of management by oncologists in France in 2019, for any type of practitioners of university hospital, or general hospital, for all type of neurotoxic anticancer drugs.
| Study group | Role | What they receive |
|---|---|---|
| Oncologists | French oncologists Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment strategy for CIPN
Name of the drug used to treat CIPN and therapeutic adjustments, relay to a pain doctor and use of drugs)
Measured: at day 1
Secondary outcomes (13)
Perception of effectiveness of the treatments used
Visual analogic scale: 0 no efficacy - 100 maximal efficacy
Measured: at day 1
Perception of safety of the treatments used to treat CIPN
Visual analogic scale: 0 unacceptable adverse effect - 100 acceptable adverse effects
Measured: at day 1
Treatment strategy for CIPN prevention
Name of the drug used to prevent CIPN and therapeutic adjustments
Measured: at day 1
Estimation by the oncologist of the percentage of patients affected by CIPN
Visual analogic scale: 0% - 100% of patients
Measured: at day 1
Proportion of assessments of the CIPN severity performed by the oncologist using a specific questionnaire
yes / no (percentage) if yes name of the questionnaire
Measured: at day 1
Proportion of CIPN assessments performed by the oncologist with a clinical examination
yes / no (percentage)
Measured: at day 1
Proportion of CIPN assessments performed by a neurological examination (neurologist)
yes / no (percentage)
Measured: at day 1
Age of oncologists
years
Measured: at day 1
Sex of oncologists
Male / female
Measured: at day 1
Organ or system speciality of oncologists
name of speciality
Measured: at day 1
Number of chemotherapy prescriptions
Number of chemotherapy
Measured: at day 1
Types of neurotoxic anticancer drugs prescribed
Name of drugs
Measured: at day 1
Working place
French region of practice and type of structure (public / private)
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start14 Jan 2019
- Primary completion23 Mar 2019
- Study completion23 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- UFR de Pharmacie (Clermont-Ferrand)
- Responsible party
- Sponsor
- Investigators
- David BALAYSSAC, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854864
- Sponsor's protocol ID
- CHU-426
- Acronym
- EVANEURO
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 24 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Selvy M, Pereira B, Kerckhove N, Busserolles J, Farsi F, Guastella V, Merle P, Pezet D, Balayssac D. Prevention, diagnosis and management of chemotherapy-induced peripheral neuropathy: a cross-sectional study of French oncologists' professional practices. Support Care Cancer. 2021 Jul;29(7):4033-4043. doi: 10.1007/s00520-020-05928-6. Epub 2021 Jan 5.
PubMed 33403401
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies: Observational and Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03854864
- Acronym / sponsor ID
- EVANEURO / CHU-426
- Keywords
- Peripheral Nervous System Diseases, Oncologists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- UFR de Pharmacie (Clermont-Ferrand)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 23 Mar 2019 (actual)
- Study completion
- 23 Mar 2019 (actual)
- First posted
- 26 Feb 2019 (actual)
- 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.
Chemotherapy induced peripheral neuropathy (CIPN) is one of the most deleterious adverse effect of neurotoxic anticancer drugs affecting up to 40% of patients. These neurotoxic anticancer agents include mainly: cisplatin (bronchopulmonary cancers), oxaliplatin (colorectal cancers), paclitaxel (breast cancers and bronchopulmonary cancers), docetaxel (breast cancers and bronchopulmonary cancers) and bortezomib (multiple myeloma).
CIPN affects not only the quality of life of patients, it also has a major impact on oncology strategy, forcing oncologists to reduce dose-intensity, to stop an ongoing chemotherapy regimen and to change therapeutic strategies, with a risk of compromising patients' survival.
There is no real preventive or curative treatment (except duloxetine) for CIPN and it is not known what is the practice of oncologists in France? However, it is essential to know the degree of sensitivity of oncologists to this problem and their practice.
With this study, the investigators propose to assess the current practices of management by oncologists in France in 2019, for any type of practitioners of university hospital, or general hospital, for all type of neurotoxic anticancer drugs.
Detailed description
This observational and cross-sectional study will be conducted as a survey using the REDCap software and the response to this survey will be done online, in real time, with an automatic, secure and centralized data collection (CHU Clermont-Ferrand).
French oncologist will be contacted by email thanks to the regional cancer networks. Answer to the survey will be done online.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncologists | – | Other: surveyFrench oncologists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- oncologist
Key inclusion criteria (1 listed)
- Oncologist
Key exclusion criteria (1 listed)
- pain physician
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 |
|---|---|---|
| surveyto assess the current practices of management by oncologists in France in 2019, for any type of practitioners of university hospital, or general hospital, for all type of neurotoxic anticancer drugs. | Other | Oncologists |
Primary outcome
Treatment strategy for CIPN
Time frame: at day 1
Name of the drug used to treat CIPN and therapeutic adjustments, relay to a pain doctor and use of drugs)
13 secondary outcomes
Perception of effectiveness of the treatments used
Time frame: at day 1
Perception of safety of the treatments used to treat CIPN
Time frame: at day 1
Treatment strategy for CIPN prevention
Time frame: at day 1
Estimation by the oncologist of the percentage of patients affected by CIPN
Time frame: at day 1
Proportion of assessments of the CIPN severity performed by the oncologist using a specific questionnaire
Time frame: at day 1
Proportion of CIPN assessments performed by the oncologist with a clinical examination
Time frame: at day 1
Proportion of CIPN assessments performed by a neurological examination (neurologist)
Time frame: at day 1
Age of oncologists
Time frame: at day 1
Sex of oncologists
Time frame: at day 1
Organ or system speciality of oncologists
Time frame: at day 1
Number of chemotherapy prescriptions
Time frame: at day 1
Types of neurotoxic anticancer drugs prescribed
Time frame: at day 1
Working place
Time frame: at day 1
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 24 May 2019.
- Derived from this study: PubMed 33403401Selvy M, Pereira B, Kerckhove N, Busserolles J, Farsi F, Guastella V, Merle P, Pezet D, Balayssac D. Prevention, diagnosis and management of chemotherapy-induced peripheral neuropathy: a cross-sectional study of French oncologists' professional practices. Support Care Cancer. 2021 Jul;29(7):4033-4043. doi: 10.1007/s00520-020-05928-6. Epub 2021 Jan 5.
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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.
David BALAYSSAC 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 Chemotherapy-induced Peripheral Neuropathy, 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 1 inclusion and 1 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 24 May 2019. 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?
Treatment strategy for CIPN (time frame: at day 1). 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 NCT03854864, which also lists 1 linked publication.
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 24 May 2019.