The Effect of Cold Therapy on Peripheral Neuropathy

NCT06488963 | Recruiting

• 1 other identifier: KOCUNIVERSITY
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Wong-Baker FACES® Pain Rating Scale

  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 Outcomes (1)

• Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module Survey

  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.

Study Arms (2)

Control group

NO INTERVENTION

Children in the control group will receive standard care. VIPN is expected to follow at the end of the third cycle, nearly three months from the first VCR dose/application. Accordingly, no additional intervention will be performed to prevent peripheral neuropathy in children in the control group. Standard care: The clinic uses no pharmacological or non-pharmacological method as standard care for preventing VIPN. For patients with VIPN in the pediatric oncology clinic, dose reduction or treatment interruption is performed. Children will be excluded from the study if such a situation occurs during the research time period.

Cold Therapy/Intervention Group

EXPERIMENTAL

In addition to standard care in the clinic, cold therapy will be applied to the children in the intervention group while they are receiving VCR in the inpatient pediatric oncology clinic. Children in the intervention group will wear cold therapy gloves and socks.To maintain the appropriate level of cold, the research assistant will replace the iced gel packs in the gloves and socks every 5 min during the treatment.

Other: NatraCure Cold Therapy gloves and socks

Interventions

NatraCure Cold Therapy gloves and socks OTHER

These gloves and socks will be adjusted and tied to the child's wrists and ankles. There are sizes suitable for all ages and the dimensions of the gloves and socks can be adjusted with a snap fastener. The gloves and socks contain a soft Lycra lining and four inner gel cold packs to ensure full length cold therapy treatments. When the children wear these gloves and socks, they can still move their fingers and toes easily. In addition, it is a great advantage that the iced gel packs do not touch the child's skin directly.

Cold Therapy/Intervention Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 7-18 years,
• receiving VCR therapy,
• diagnosed with leukemia, medulloblastoma, rhabdomyosarcoma, or Wilms tumor,
• able to speak and understand Turkish
• receiving initial treatment
• consent to participate in the research project.

You may not qualify if:

• receiving a dose of VCR \<2.5 mg/m2,
• receiving VCR and azole antifungal treatment simultaneously,
• a hematological malignancy with neurological disease,
• a history of peripheral neuropathy,
• diabetes,
• self-reported cold sensitivity.
• Additionally, children who receive chemotherapy or other treatment using the peripheral veins of their hands or feet will not be included since the cold application is contraindicated.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Eyşan Hanzade Umaç

CONTACT

506848841; euma14@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: The sample will consist of pediatric oncology patients aged 7 to 18 with select diagnoses (see inclusion criteria) who receive VCR. The G\*Power software was used to analyze the sample's size (Faul et al., 2007). Since no similar previous study was identified, we aimed to reach a medium effect size for sample size calculation. Based on a medium effect size (f:0.40), 80% (1 - β error) power, and 95% (α error) confidence level within two groups and six repeated measurements, the sample size was calculated as 16 for each group, and a total of 32 children. Considering the expected dropout rate, the number was increased %10 and so 36 children will be recruited.

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: January 15, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)