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

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

NCT ID: NCT05759052

Condition: Chemotherapy-induced Peripheral Neuropathy

Conditions: Official terms:
Leukemia
Peripheral Nervous System Diseases

Conditions: Keywords:
vincristine-induced peripheral neuropathy
pediatric leukemia
cancer survivor

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Behavioral
Intervention name: self-administered questionnaire
Description: Patients will answer to a self- administered questionnaire exploring chemotherapy-induced peripheral neuropathy and related comorbidities
Arm group label: Cohort of adult survivors having been treated by vincristine

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.

Detailed 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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CHU Clermont-Ferrand

Address:
City: Clermont-Ferrand
Country: France

Status: Recruiting

Contact:
Last name: David Balayssac, PhD, PharmD

Start date: May 5, 2023

Completion date: July 31, 2025

Lead sponsor:
Agency: University Hospital, Clermont-Ferrand
Agency class: Other

Source: University Hospital, Clermont-Ferrand

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05759052