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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2019
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
survey
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.

Locations

Country Name City State
France Chu Clermont-Ferrand Clermont-Ferrand

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand UFR de Pharmacie (Clermont-Ferrand)

Country where clinical trial is conducted

France, 

Outcome

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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