Vincristine-induced Peripheral Neuropathy in Adult Survivors of Childhood and Adolescent Leukemia (CIPN-LEA)

Long-term Evaluation of Vincristine-induced Peripheral Neuropathy in Adult Survivors of a Multicenter Prospective Cohort of Childhood and Adolescent Leukemia (LEA Cohort): a Multicenter Cross-sectional Study

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Behavioral: self-administered questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 467

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU clermont-ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients will answer to a self- administered questionnaire exploring chemotherapy-induced peripheral neuropathy and related comorbidities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor chemotherapy-induced peripheral neuropathy	Scores of the motor subscale of the QLQ-CIPN20 questionnaire (quality of life questionnaire - chemotherapy-induced peripheral neuropathy 20 questions) scores : 0 least - 100 worst	day 1
Pain severity	Scores of pain severirty assessed with a visual analogic scale scores : 0 no pain - 10 maximal pain	day 1
Neuropathic pain	Scores of the DN4 interview questionnaire (Douleur neuropathique 4 questions) Scores : 0 least - 7 worst Threshold for neuropathic pain : 3	day 1
Ongoing analgesic treatment	Reporting of ongoing analgesic treatment declared by the patient	day 1
Anxiety severity	Scores of the anxiety subscale of the HADS questionnaire (Hospital anxiety and depression scale) Anxiety scores: 0 least - 21 worst Normal scores: ≤7 Borderline or suggestive of possible anxiety: 8-10 Indicative of anxiety: ≥11	day 1
Depression severity	Scores of the depression subscale of the HADS questionnaire (Hospital anxiety and depression scale) Depression scores: 0 least - 21 worst Normal scores: ≤7 Borderline or suggestive of possible depression: 8-10 Indicative of depression: ≥11	day 1
Health-related quality of life	Scores of the SF36 questionnaire (short-form 36) for each item: 0 worst - 100 best	day 1
Physical activity and sedentarity	GPAQ questionnaire (Global Physical Activity Questionnaire) Work-related physical activity (minutes) Leisure-related physical activity (minutes) Time spent sitting (minutes)	day 1
Deprivation	Scores of the EPICES questionnaire (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé) Scores: 0 best - 100 worst	day 1
Use of legal and illegal psychoactive drugs	Reporting of legal psychoactive drug use (alcohol, tobacco, e-cigarette, psychoactive medication, cannabidiol, and other), and illegal psychoactive drug use (cannabis, and other)	day 1
Oncological characteristics	Type of hematological malignancy and date of diagnosis ; Chemotherapy received: vincristine (date of last course and cumulative dose), anthracyclines (cumulative dose) ; Radiation therapy received: central nervous system irradiation and total dose, total body irradiation and total dose ; Hematopoietic stem cell (HSC) transplant: autograft or allograft, and date of transplant(s) ; Relapse (date)	day 1
Oncological characteristics	Type of hematological malignancy, date of diagnosis, and relapse (date)	day 1
Anticancer drugs received	vincristine (date of last course and cumulative dose), and anthracyclines (cumulative dose)	day 1
Radiation therapy received	Central nervous system irradiation (total dose), total body irradiation (total dose)	day 1
Hematopoietic stem cell transplant	Autograft or allograft, and date of transplant(s)	day 1
Sociodemographic characteristics	Age at the time of the response to the study questionnaire ; Age at diagnosis of hematological malignancy ; Gender ; Weight, height, body surface area, weight-for-age and sex-percentile at diagnosis ; Weight, height and BMI at time of response ; Intercurrent pathology at time of response ; socio-professional group	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: David BALAYSSAC, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): November 4, 2025
• Study Completion (Actual): November 4, 2025

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: cancer survivor; vincristine-induced peripheral neuropathy; pediatric leukemia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neuromuscular Diseases; Leukemia; Peripheral Nervous System Diseases
• Other Study ID Numbers: PHRC IR 2021 BALAYSSAC; 2022-A01758-35 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No