Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies (EVANEURO)

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.

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Other: survey

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 Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

oncologist

Description

Inclusion Criteria:

• Oncologist

Exclusion Criteria:

• pain physician

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Oncologists; French oncologists	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of effectiveness of the treatments used	Visual analogic scale: 0 no efficacy - 100 maximal efficacy	at day 1
Perception of safety of the treatments used to treat CIPN	Visual analogic scale: 0 unacceptable adverse effect - 100 acceptable adverse effects	at day 1
Treatment strategy for CIPN prevention	Name of the drug used to prevent CIPN and therapeutic adjustments	at day 1
Estimation by the oncologist of the percentage of patients affected by CIPN	Visual analogic scale: 0% - 100% of patients	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	at day 1
Proportion of CIPN assessments performed by the oncologist with a clinical examination	yes / no (percentage)	at day 1
Proportion of CIPN assessments performed by a neurological examination (neurologist)	yes / no (percentage)	at day 1
Age of oncologists	years	at day 1
Sex of oncologists	Male / female	at day 1
Organ or system speciality of oncologists	name of speciality	at day 1
Number of chemotherapy prescriptions	Number of chemotherapy	at day 1
Types of neurotoxic anticancer drugs prescribed	Name of drugs	at day 1
Working place	French region of practice and type of structure (public / private)	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: UFR de Pharmacie (Clermont-Ferrand)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2019
• Primary Completion (ACTUAL): March 23, 2019
• Study Completion (ACTUAL): March 23, 2019

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (ACTUAL): February 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Peripheral Nervous System Diseases; Oncologists
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: CHU-426

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No