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NCT Number: NCT05759052

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-administered questionnaire

Behavioral

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

Primary outcomes

  1. Sensitive chemotherapy-induced peripheral neuropathy

    Time frame: day 1

    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

Secondary outcomes

  1. Motor chemotherapy-induced peripheral neuropathy

    Time frame: day 1

    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

  2. Pain severity

    Time frame: day 1

    Scores of pain severirty assessed with a visual analogic scale scores : 0 no pain - 10 maximal pain

  3. Neuropathic pain

    Time frame: day 1

    Scores of the DN4 interview questionnaire (Douleur neuropathique 4 questions) Scores : 0 least - 7 worst Threshold for neuropathic pain : 3

  4. Ongoing analgesic treatment

    Time frame: day 1

    Reporting of ongoing analgesic treatment declared by the patient

  5. Anxiety severity

    Time frame: day 1

    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

  6. Depression severity

    Time frame: day 1

    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

  7. Health-related quality of life

    Time frame: day 1

    Scores of the SF36 questionnaire (short-form 36) for each item: 0 worst - 100 best

  8. Physical activity and sedentarity

    Time frame: day 1

    GPAQ questionnaire (Global Physical Activity Questionnaire) Work-related physical activity (minutes) Leisure-related physical activity (minutes) Time spent sitting (minutes)

  9. Deprivation

    Time frame: day 1

    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

  10. Use of legal and illegal psychoactive drugs

    Time frame: day 1

    Reporting of legal psychoactive drug use (alcohol, tobacco, e-cigarette, psychoactive medication, cannabidiol, and other), and illegal psychoactive drug use (cannabis, and other)

  11. Oncological characteristics

    Time frame: day 1

    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)

  12. Oncological characteristics

    Time frame: day 1

    Type of hematological malignancy, date of diagnosis, and relapse (date)

  13. Anticancer drugs received

    Time frame: day 1

    vincristine (date of last course and cumulative dose), and anthracyclines (cumulative dose)

  14. Radiation therapy received

    Time frame: day 1

    Central nervous system irradiation (total dose), total body irradiation (total dose)

  15. Hematopoietic stem cell transplant

    Time frame: day 1

    Autograft or allograft, and date of transplant(s)

  16. Sociodemographic characteristics

    Time frame: day 1

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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

Acronym: CIPN-LEA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2023
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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