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NCT Number: NCT03854864

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Oncologist

Exclusion criteria

  • pain physician

Treatment and study plan

Survey

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Perception of effectiveness of the treatments used

    Time frame: at day 1

    Visual analogic scale: 0 no efficacy - 100 maximal efficacy

  2. Perception of safety of the treatments used to treat CIPN

    Time frame: at day 1

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

  3. Treatment strategy for CIPN prevention

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: at day 1

    yes / no (percentage)

  7. Proportion of CIPN assessments performed by a neurological examination (neurologist)

    Time frame: at day 1

    yes / no (percentage)

  8. Age of oncologists

    Time frame: at day 1

    years

  9. Sex of oncologists

    Time frame: at day 1

    Male / female

  10. Organ or system speciality of oncologists

    Time frame: at day 1

    name of speciality

  11. Number of chemotherapy prescriptions

    Time frame: at day 1

    Number of chemotherapy

  12. Types of neurotoxic anticancer drugs prescribed

    Time frame: at day 1

    Name of drugs

  13. Working place

    Time frame: at day 1

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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • UFR de Pharmacie (Clermont-Ferrand)

Registry information

Official study title

Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies: Observational and Cross-sectional Study

Acronym: EVANEURO

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2019
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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