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NCT Number: NCT07326930

Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia

The goal of this study is to explore the trajectory patterns of chemotherapy induced peripheral neuropathy over the course of chemotherapy and identify predictors of distinct trajectories in children with acute lymphoblastic leukemia. A perspective longitudinal study design is utilized. Chemotherapy induced peripheral neuropathy was assessed at one week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4 (T5), two weeks after T5 (T6), two weeks after T5 (T7). Patients' demographic and clinical characteristics, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy are obtained at baseline.

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Key information

Conditions

Acute Lymphoblastic Leukemia ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital,, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed with acute lymphoblastic leukemia
  • aged from 8 to 17 years
  • will receive vincristine according the Chinese Children's Cancer Group Acute Lymphoblastic Leukemia-2020 Project (CCCG-ALL-2020)
  • conscious with sufficient cognitive abilities to understand and express their physical state and psychological feelings accurately
  • written informed assent is obtained from the children and their parents for their participation in the study

Exclusion criteria

  • participating other experimental trials, such as electrical stimulation, exercise therapy may improve CIPN symptoms.
  • with severe complications, including but not limited to significant heart, brain, or lung function failure.
  • had peripheral neuropathy symptoms caused by other diseases like genetic diseases, spinal cord injury.
  • had neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy).
  • had central nervous system cancer or secondary cancer.
  • had multiple treatment like radiotherapy.

Treatment and study plan

Primary outcomes

  1. Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale

    Time frame: One week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4(T5), two weeks after T5(T6), two weeks after T6(T7)

    For measuring participants' peripheral neuropathy induced by chemotherapy. The total score ranges from 0 to 65 with higher scores indicating more severe chemotherpay induced peripheral neuropathy.

Other outcomes

  1. The therapy-related symptom checklist for children (TRSC-C)

    Time frame: Baseline

    TRSC-C is used to assess the participants' physcial symptoms. This checklist contains 30 items divided into 7 factors (1) nutrition-related, (2) psychosocial/ central nervous system (CNS), (3) oropharyngeal, (4) bone marrow toxicity/neuropathy, (5) skin/other toxicities, (6) neurotoxicities, and (7) respiratory/other symptoms. The total TRSC-C score is computed as the average of the symptom scores for all 30 symptoms. Higher scores indicating greater severity of symptoms

  2. Screening tool for the assessment of malnutrition in pediatrics, STAMP

    Time frame: Baseline

    The STAMP is used to assess the nutritional status of participants. The nutritional risk is divided into low risk (0-1 points), moderate risk (2-3 points), and high risk (≥4 points) based on the total score (0-9 points).

  3. National Comprehensive Cancer Network (NCCN) distress thermometer (DT)

    Time frame: Baseline

    The NCCN-DT was used to assess psychological distress among participants. A cut off value ≥4 for single-item DT screening tool is recommended to indicate a distressed patient.

  4. A specific item - 'subjective sleep quality' from the Pittsburgh Sleep Quality Index scale, PSQI

    Time frame: Baseline

    A specific item - 'subjective sleep quality' from PSQI is used to assess the participants' sleep quality. Answer is coded into a 0-3 score for this item, with higher score reflect poor sleep quality.

  5. Leisure Score Index (LSI) of the Godin-Leisure-Time Exercise Questionnaire (GLTEQ)

    Time frame: Baseline

    Leisure Score Index is used to assess the participants' physical activity level. A score of 24 or over indicate active physical activity and higher scores indicating higher levels of physical activity.

  6. Multidimensional Scale of Perceived Social Support, MSPSS

    Time frame: Baseline

    MSPSS is used to assess the participants' perceived social support. The total score ranges from 12 to 84, with higher mean score indicate greater level of Perceived Social Support.

  7. Paediatric Cancer Coping Scale, PCCS

    Time frame: Baseline

    PCCS is used to assess the participants' coping strategies. This scale is divided into three domains: cognitive coping (14 items), problem-oriented coping (9 items) and defensive coping (10 items) with total 33 items. Each item is performed on a 4-point Likert scale from 0 (never) to 3 (always), with higher scores indicating the most frequently used coping strategies.

Study contacts

Contact information is provided by the study sponsor or research team.

Ka Yan Ho, PhD

CONTACT

[email protected]

852-27666417

Ting MAO

CONTACT

[email protected]

852-54844554

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia: A Perspective Longitudinal Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

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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