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

NCT05759052 | Completed

• 2 other identifiers: PHRC IR 2021 BALAYSSAC2022-A01758-35
• Study Type: observational
• Target: 467
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

vincristine-induced peripheral neuropathy; pediatric leukemia; cancer survivor

Outcome Measures

Primary Outcomes (1)

• Sensitive chemotherapy-induced peripheral neuropathy

  Scores of the sensitive subscale of the QLQ-CIPN20 questionnaire (quality of life questionnaire - chemotherapy-induced peripheral neuropathy 20 questions) scores : 0 least - 100 worst

  day 1

Secondary Outcomes (16)

• Motor chemotherapy-induced peripheral neuropathy

  day 1

• Pain severity

  day 1

• Neuropathic pain

  day 1

• Ongoing analgesic treatment

  day 1

• Anxiety severity

  day 1

Study Arms (1)

Cohort of adult survivors having been treated by vincristine

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

Behavioral: self-administered questionnaire

Interventions

self-administered questionnaire BEHAVIORAL

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

Cohort of adult survivors having been treated by vincristine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled from the French Childhood Cancer Survivor Study For Leukaemia (LEA Cohort), in each particiapting centers

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

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 13, 2023
• First Posted: March 8, 2023
• Study Start: May 12, 2023
• Primary Completion: November 4, 2025
• Study Completion: November 4, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)