Actively Recruiting

Phase Not Applicable
Age: 7Years - 18Years
All Genders
NCT06488963

The Effect of Cold Therapy on Peripheral Neuropathy

Led by Koç University · Updated on 2024-07-05

36

Participants Needed

1

Research Sites

98 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

The Effect of Cold Therapy on Peripheral Neuropathy

Who Can Participate

Age: 7Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 7 to 18 years
  • Receiving vincristine 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
Not Eligible

You will not qualify if you...

  • Receiving a vincristine dose less than 2.5 mg/m2
  • Receiving vincristine and azole antifungal treatment at the same time
  • Having a hematological malignancy with neurological disease
  • History of peripheral neuropathy
  • Diabetes
  • Self-reported cold sensitivity
  • Receiving chemotherapy or other treatment through peripheral veins of hands or feet, making cold application contraindicated

AI-Screening

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Trial Site Locations

Total: 1 location

1

Koc University

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

E

Eyşan Hanzade Umaç

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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The Effect of Cold Therapy on Peripheral Neuropathy | DecenTrialz