NCT03854864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2019

Completed
Last Updated

May 24, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

February 21, 2019

Last Update Submit

May 23, 2019

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Peripheral Nervous System DiseasesOncologists

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Perception of effectiveness of the treatments used

    at day 1

  • Perception of safety of the treatments used to treat CIPN

    at day 1

  • Treatment strategy for CIPN prevention

    at day 1

  • Estimation by the oncologist of the percentage of patients affected by CIPN

    at day 1

  • Proportion of assessments of the CIPN severity performed by the oncologist using a specific questionnaire

    at day 1

  • +8 more secondary outcomes

Study Arms (1)

Oncologists

French oncologists

Other: survey

Interventions

surveyOTHER

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.

Oncologists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

oncologist

You may qualify if:

  • Oncologist

You may not qualify if:

  • pain physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 33403401DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David BALAYSSAC

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 26, 2019

Study Start

January 14, 2019

Primary Completion

March 23, 2019

Study Completion

March 23, 2019

Last Updated

May 24, 2019

Record last verified: 2019-02

Locations

FR(1)