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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05759052
Acronym
CIPN-LEA
Enrollment
467
Registered
2023-03-08
Start date
2023-05-12
Completion date
2025-11-04
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

vincristine-induced peripheral neuropathy, pediatric leukemia, cancer survivor

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.

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.

Interventions

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitive chemotherapy-induced peripheral neuropathyday 1Scores of the sensitive subscale of the QLQ-CIPN20 questionnaire (quality of life questionnaire - chemotherapy-induced peripheral neuropathy 20 questions) scores : 0 least - 100 worst

Secondary

MeasureTime frameDescription
Pain severityday 1Scores of pain severirty assessed with a visual analogic scale scores : 0 no pain - 10 maximal pain
Neuropathic painday 1Scores of the DN4 interview questionnaire (Douleur neuropathique 4 questions) Scores : 0 least - 7 worst Threshold for neuropathic pain : 3
Ongoing analgesic treatmentday 1Reporting of ongoing analgesic treatment declared by the patient
Anxiety severityday 1Scores 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
Depression severityday 1Scores 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
Health-related quality of lifeday 1Scores of the SF36 questionnaire (short-form 36) for each item: 0 worst - 100 best
Physical activity and sedentarityday 1GPAQ questionnaire (Global Physical Activity Questionnaire) Work-related physical activity (minutes) Leisure-related physical activity (minutes) Time spent sitting (minutes)
Motor chemotherapy-induced peripheral neuropathyday 1Scores of the motor subscale of the QLQ-CIPN20 questionnaire (quality of life questionnaire - chemotherapy-induced peripheral neuropathy 20 questions) scores : 0 least - 100 worst
Use of legal and illegal psychoactive drugsday 1Reporting of legal psychoactive drug use (alcohol, tobacco, e-cigarette, psychoactive medication, cannabidiol, and other), and illegal psychoactive drug use (cannabis, and other)
Oncological characteristicsday 1Type 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)
Anticancer drugs receivedday 1vincristine (date of last course and cumulative dose), and anthracyclines (cumulative dose)
Radiation therapy receivedday 1Central nervous system irradiation (total dose), total body irradiation (total dose)
Hematopoietic stem cell transplantday 1Autograft or allograft, and date of transplant(s)
Sociodemographic characteristicsday 1Age 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
Deprivationday 1Scores 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026