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The Effect of Cold Therapy on Peripheral Neuropathy

NCT06488963 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-07-05

No results posted yet for this study

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

Interventions

OTHER

NatraCure Cold Therapy gloves and socks

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.

Sponsors & Collaborators

  • Koç University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06488963 on ClinicalTrials.gov