Clinical trial NCT05759052: Vincristine-induced Peripheral Neuropathy in Adult Survivors of Childhood and Adolescent Leukemia
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: vincristine-induced peripheral neuropathy
pediatric leukemia
cancer survivor
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility 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

Primary outcomes:
measure: Sensitive chemotherapy-induced peripheral neuropathy
timeFrame: day 1
Secondary outcomes:
measure: Motor chemotherapy-induced peripheral neuropathy
timeFrame: day 1
measure: Pain severity
timeFrame: day 1
measure: Neuropathic pain
timeFrame: day 1
measure: Ongoing analgesic treatment
timeFrame: day 1
measure: Anxiety severity
timeFrame: day 1
measure: Depression severity
timeFrame: day 1
measure: Health-related quality of life
timeFrame: day 1
measure: Physical activity and sedentarity
timeFrame: day 1
measure: Deprivation
timeFrame: day 1
measure: Use of legal and illegal psychoactive drugs
timeFrame: day 1
measure: Oncological characteristics
timeFrame: day 1
measure: Oncological characteristics
timeFrame: day 1
measure: Anticancer drugs received
timeFrame: day 1
measure: Radiation therapy received
timeFrame: day 1
measure: Hematopoietic stem cell transplant
timeFrame: day 1
measure: Sociodemographic characteristics
timeFrame: day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: David Balayssac
role: PRINCIPAL_INVESTIGATOR
References: