Screening for Chemotherapy Induced Peripheral neuropathy: Determining the Effectiveness of an Early Identification Screening Programme

  • Hartley, Helen (PI)
  • Pizer, Barry (PI)
  • Gildersleve, Kate (CoI)

Project Details


Research Design
Feasibility Prospective RCT – usual care versus CIPN screening programme (early identification) and usual care.
Research Aim/Question
What is the feasibility of conducting a RCT to examine the impact of an early identification screening programme for children at high risk of CIPN on children’s long-term physical outcomes?
Study Participants
Newly diagnosed children, 4-<18 years at high risk of CIPN (children with Acute Lymphoblastic Leukaemia (ALL), Wilms Tumour, Rhabdomyosarcoma, Low grade brain tumour on LGG 2 Protocol).
Planned Sample Size
30 participants are planned to be recruited with 15 allocated into each group.
Treatment duration
Children allocated to the screening group will be screened using the Ped-m TNS and the Edinburgh Visual Gait Score as follows: S1 at diagnosis, S2 4 weeks, S3 8 weeks, S4 12 weeks, S5 16 weeks and S6 at 24 weeks post diagnosis
Follow up duration
Both groups of children will be assessed at A1 at diagnosis, and A2 6 months and A3 12 months post diagnosis using 8 outcome measures (BOT-II, Oxford questionnaire, TUG, 10MWT, Lansky Play Performance Scale, 9HPT, ankle ROM and dorsiflexion muscle strength).
Study Period
April 2024-September 2024 (Each child’s participation period in the study is 12 months)
Primary Objectives
To determine the feasibility of conducting a RCT examining the impact of a screening programme undertaken in the first 6 months of chemotherapy treatment for children at high risk of CIPN.
Primary Outcome Measures
Process measures of feasibility
1) The number of children who are identified
2) The number of children who are recruited
3) Willingness to be randomised
4) Number of children who withdraw/drop out
Assessment measures of feasibility
1) Number of children who complete all 3 assessment time points
2) Time taken to complete assessments
3) Number of children who complete all screening assessments
Any issues with the outcome measures or screening tools will be recorded
Secondary Objectives
To provide preliminary information as to whether closer monitoring (via a screening programme) of children at high risk of CIPN results in:
1) Improved short- and long-term physical outcomes
2) Improved detection rates of CIPN
3) Impacts on cumulative dosage, dose modification or omissions of chemotherapy; and
4) Provide data to inform a sample size for a future definitive trial
Secondary Outcome Measures (Physical Outcomes, primary end point 12 months)
1) BOT-II (Bruininks-Oseretsky Test of Motor Proficiency, Second Edition):
2) Oxford foot and ankle questionnaire
3) Secondary physical outcomes: Timed up and go (TUG), 10-metre walk test (10MWT), Lanksy Play performance scale, 9-hole peg test (9HPT), ankle range of movement (ROM) and dorsiflexion muscle strength.
4) Chemotherapy related outcomes: number of dose modifications, cumulative dose of chemotherapy
5) CIPN outcomes: percentage of children in each group; a) identified as having CIPN, b) receiving medication management for CIPN.
5) Physiotherapy outcomes: number of children who require orthotics, time from diagnosis to physiotherapy intervention (if any required).

Layman's description

Children with cancer often have treatment that has negative side effects that may develop secondary to treatment. Physical side effects may include chemotherapy induced peripheral neuropathy (CIPN). CIPN describes damage to the peripheral nervous system.
This feasibility RCT aims to examine whether early identification of possible side effects through a screening programme can have an impact on children at high risk of CIPN on children’s long-term physical outcomes.
Children (n=30) will be recruited to two groups: (1) usual care plus screening (n=15), and (2) usual care (n=15).
Short titleThe SCIP Study
Effective start/end date1/04/2330/09/24

UN Sustainable Development Goals

In 2015, UN member states agreed to 17 global Sustainable Development Goals (SDGs) to end poverty, protect the planet and ensure prosperity for all. This project contributes towards the following SDG(s):

  • SDG 3 - Good Health and Well-being


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