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

Last updated: November 30, 2023
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Neurologic Disorders

Treatment

self-administered questionnaire

Clinical Study ID

NCT05759052
PHRC IR 2021 BALAYSSAC
2022-A01758-35
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult patient (> 18-year) who received a vincristine-based chemotherapy for hematologicalmalignancy in childhood

Exclusion

Exclusion Criteria:

  • Secondary cancer (leukemia and/or cancer)
  • Active oncological pathology
  • Current cancer treatment
  • Adults protected

Study Design

Total Participants: 750
Treatment Group(s): 1
Primary Treatment: self-administered questionnaire
Phase:
Study Start date:
May 05, 2023
Estimated Completion Date:
July 31, 2025

Study Description

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.

Connect with a study center

  • CHU Clermont-Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

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