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

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Completed
• CT.gov ID: NCT03854864
• Collaborator: UFR de Pharmacie (Clermont-Ferrand) (Other)
• Enrollment: 216
• Location: 1
• Actual Duration (Months): 2.2
• Patients Per Site Per Month: 96.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Peripheral Neuropathy	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 Design

• Study Type: Observational
• Actual Enrollment: 216 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies: Observational and Cross-sectional Study
• Actual Study Start Date: Jan 14, 2019
• Actual Primary Completion Date: Mar 23, 2019
• Actual Study Completion Date: Mar 23, 2019

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Treatment strategy for CIPN [at day 1]

   Name of the drug used to treat CIPN and therapeutic adjustments, relay to a pain doctor and use of drugs)

Secondary Outcome Measures

1. Perception of effectiveness of the treatments used [at day 1]

   Visual analogic scale: 0 no efficacy - 100 maximal efficacy

2. Perception of safety of the treatments used to treat CIPN [at day 1]

   Visual analogic scale: 0 unacceptable adverse effect - 100 acceptable adverse effects

3. Treatment strategy for CIPN prevention [at day 1]

   Name of the drug used to prevent CIPN and therapeutic adjustments

4. Estimation by the oncologist of the percentage of patients affected by CIPN [at day 1]

   Visual analogic scale: 0% - 100% of patients

5. Proportion of assessments of the CIPN severity performed by the oncologist using a specific questionnaire [at day 1]

   yes / no (percentage) if yes name of the questionnaire

6. Proportion of CIPN assessments performed by the oncologist with a clinical examination [at day 1]

   yes / no (percentage)

7. Proportion of CIPN assessments performed by a neurological examination (neurologist) [at day 1]

   yes / no (percentage)

8. Age of oncologists [at day 1]

   years

9. Sex of oncologists [at day 1]

   Male / female

10. Organ or system speciality of oncologists [at day 1]

    name of speciality

11. Number of chemotherapy prescriptions [at day 1]

    Number of chemotherapy

12. Types of neurotoxic anticancer drugs prescribed [at day 1]

    Name of drugs

13. Working place [at day 1]

    French region of practice and type of structure (public / private)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Oncologist

Exclusion Criteria:

• pain physician

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

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

Investigators

• Principal Investigator: David BALAYSSAC, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT03854864
• Other Study ID Numbers: CHU-426
• First Posted: Feb 26, 2019
• Last Update Posted: May 24, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Clermont-Ferrand: Peripheral Nervous System Diseases; Oncologists
• Additional relevant MeSH terms: Peripheral Nervous System Diseases

Study Results

No Results Posted as of May 24, 2019