Vincristine-induced Peripheral Neuropathy in Adult Survivors of Childhood and Adolescent Leukemia

NCT ID: NCT05759052

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

467 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-12

Study Completion Date

2025-11-04

Brief Summary

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Vincristine is a major anticancer agent in the management of hematological malignancies. One of the main side effects is chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a characteristic side effect of neurotoxic anticancer drugs. CIPN associated with vincristine is typically characterized by distal and symmetrical sensory symptoms (dysesthesia and paresthesia). Motor and vegetative symptoms can also be found. The prevalence of CIPN associated with vincristine during treatment ranges from 12 to 100% in children (depending on the endpoint).

The aim of this cross-sectionnal study will be to explore the CIPN prevalence and severity in adult survivors of childhood leukemia and having been treated by vincristine.

Detailed Description

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Adult survivors of chidlhood leukemia and having been treated by vincristine will be contacted from the French childhood cancer survivor study for leukaemia (LEA Cohort) in order to seek their participation agreement.

Thereafter patients will received a self-administered questionnaire exploring the chemotherapy-induced peripheral neuropathy and related comorbidities (pain, neuropathic pain, anxiety, depression, health-related quality of life, substance use, physical activity, deprivation). Oncological and sociodemographic characteristics of participants will be recorded.

Conditions

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Chemotherapy-induced Peripheral Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cohort of adult survivors having been treated by vincristine

Cohort of adult survivors having been treated by vincristine for a childhood leukemia

self-administered questionnaire

Intervention Type BEHAVIORAL

Patients will answer to a self- administered questionnaire exploring chemotherapy-induced peripheral neuropathy and related comorbidities

Interventions

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self-administered questionnaire

Patients will answer to a self- administered questionnaire exploring chemotherapy-induced peripheral neuropathy and related comorbidities

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- adult patient (\> 18-year) who received a vincristine-based chemotherapy for hematological malignancy in childhood

Exclusion Criteria

* Secondary cancer (leukemia and/or cancer)
* Active oncological pathology
* Current cancer treatment
* Adults protected
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Balayssac

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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2022-A01758-35

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC IR 2021 BALAYSSAC

Identifier Type: -

Identifier Source: org_study_id

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