Chemotherapy-induced Peripheral Neuropathy Clinical Trial
— EVANEUROOfficial title:
Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies: Observational and Cross-sectional Study
NCT number | NCT03854864 |
Other study ID # | CHU-426 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 14, 2019 |
Est. completion date | March 23, 2019 |
Verified date | February 2019 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 216 |
Est. completion date | March 23, 2019 |
Est. primary completion date | March 23, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Oncologist Exclusion Criteria: - pain physician |
Country | Name | City | State |
---|---|---|---|
France | Chu Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | UFR de Pharmacie (Clermont-Ferrand) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment strategy for CIPN | Name of the drug used to treat CIPN and therapeutic adjustments, relay to a pain doctor and use of drugs) | at day 1 | |
Secondary | Perception of effectiveness of the treatments used | Visual analogic scale: 0 no efficacy - 100 maximal efficacy | at day 1 | |
Secondary | Perception of safety of the treatments used to treat CIPN | Visual analogic scale: 0 unacceptable adverse effect - 100 acceptable adverse effects | at day 1 | |
Secondary | Treatment strategy for CIPN prevention | Name of the drug used to prevent CIPN and therapeutic adjustments | at day 1 | |
Secondary | Estimation by the oncologist of the percentage of patients affected by CIPN | Visual analogic scale: 0% - 100% of patients | at day 1 | |
Secondary | Proportion of assessments of the CIPN severity performed by the oncologist using a specific questionnaire | yes / no (percentage) if yes name of the questionnaire | at day 1 | |
Secondary | Proportion of CIPN assessments performed by the oncologist with a clinical examination | yes / no (percentage) | at day 1 | |
Secondary | Proportion of CIPN assessments performed by a neurological examination (neurologist) | yes / no (percentage) | at day 1 | |
Secondary | Age of oncologists | years | at day 1 | |
Secondary | Sex of oncologists | Male / female | at day 1 | |
Secondary | Organ or system speciality of oncologists | name of speciality | at day 1 | |
Secondary | Number of chemotherapy prescriptions | Number of chemotherapy | at day 1 | |
Secondary | Types of neurotoxic anticancer drugs prescribed | Name of drugs | at day 1 | |
Secondary | Working place | French region of practice and type of structure (public / private) | at day 1 |
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