The Effect of Cold Therapy on Peripheral Neuropathy
NCT Number: NCT06488963
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peripheral Neuropathy
Interventions: OTHER: NatraCure Cold Therapy gloves and socks
Sponsor: Koç University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-15
Completion Date: 2024-12
Locations: Koc University, Istanbul, Turkey

Summary:
This study examines the feasibility, acceptability, and efficacy of cold therapy on vincristine-induced peripheral neuropathy (VIPN) in pediatric patients with cancer.

Vincristine (VCR) is one of the most used vinca alkaloid chemotherapy in pediatric oncology patients. It leads to symptoms of peripheral neuropathy, numbness in the hands and feet, tingling, muscle/joint pain, burning sensation, decreased peripheral reflexes, and constipation. These symptoms negatively affect the daily life and quality of life of children. Therefore, it is essential to managing peripheral neuropathy. We aim to decrease the level of VIPN and pain and improve patients' quality of life.

Unfortunately, the neurotoxicity mechanisms of vinca alkaloids are not well known, which is one of the significant limitations in developing effective treatments to prevent VIPN among pediatric oncology patients. We were unable to locate a randomized controlled trial that has evaluated the effectiveness, tolerability, and acceptability of cold therapy on VIPN for pediatric oncology patients. Our study findings will be the first in Turkish national and international literature, and we believe that our results will provide evidence for clinical nursing practice.

Primary Outcome Measures: National Cancer Institute Common Terminology Criteria for Adverse Events v5 Peripheral Neuropathy Scale, The NCI CTCAE version 5.0 (ctep.cancer.gov) includes toxicity criteria for adverse events such as peripheral sensory and motor neuropathy, constipation, and neuralgia. The grading scale, used by health professionals is from 0-5, with 0=no toxicity and 5=death. In this study, a research assistant (PhD student in pediatric nursing) responsible for data collection will be trained to perform CTCAE scoring, review all medical records, and assign CTCAE version 5.0 sensory and motor scores according to the published criteria based on clinician documentation of signs and symptoms., Before starting each VCR application, the child's VIPN in the last week post the previous application will be evaluated. One week after the last VCR dose, the child's VIPN will be evaluated.
Secondary Outcome Measures: Wong-Baker FACES® Pain Rating Scale, This scale consists of six facial expressions. Facial expressions range from 0 points "no pain-very happy" to 10 points "unbearable pain-crying" (Wong-Baker FACES Foundation, 2016). The self-report scale is commonly used for children aged 3-18 (Martin et al., 2018). It has good validity and reliability for measuring pain intensity (Ball et al., 2017), and is psychometrically appropriate and widely used in clinical practice (Stinson et al., 2006). The psychometric properties of this scale are also suitable for evaluation by parent proxy (Schiavenato, 2008). The scale has been translated into Turkish. (Wong-Baker FACES Foundation, 2016). For the present study, the Wong-Baker FACES® scale will be used for evaluating children's self-report and parental reports of the child's pain. This pain scale is commonly used in Turkey to evaluate children's pain. It is used as a standard measurement tool in the pain assessment of children aged 3-18 in all pediatric clinics in Turkey., Before starting each VCR application, the child's pain in the last week post the previous application will be evaluated. One week after the last VCR dose, the child's pain will be evaluated.
Other Outcome Measures: Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module Survey, This scale was developed to measure the health-related QoL of children and adolescents aged 2-18 years (Varni et al., 2002). The reliability and validity of the Turkish Version of the PedsQL 3.0 Cancer Module testing was performed by Kabak et al. (2016). The PedsQL 3.0 Cancer Module was designed to measure pediatric cancer-specific health-related QoL. The 27-item multidimensional PedsQL 3.0 Cancer Module Acute Version encompasses 8 subscales: 1) pain and hurt (2 items), 2) nausea (5 items), 3) procedural anxiety (3 items), 4) treatment anxiety (3 items), 5) worry (3 items), 6) cognitive problems (5 items), 7) perceived physical appearance (3 items), and 8) communication (3 items). The child self-report and parent-proxy report are filled in considering QoL over the previous seven days., Before starting each VCR application, the child's QoL in the last week post the previous application will be evaluated. One week after the last VCR dose, the child's QoL will be evaluated.