Actively Recruiting
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
Eligibility Criteria
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
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
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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