The Effect of Cold Therapy on Peripheral Neuropathy: A Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Koc University
RECRUITING
Istanbul
Contact Information
Primary
Eyşan Hanzade Umaç
euma14@ku.edu.tr
506848841
Time Frame
Start Date: 2023-01-15
Estimated Completion Date: 2024-12
Participants
Target number of participants: 36
Treatments
No_intervention: Control group
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.
Experimental: Cold Therapy/Intervention Group
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.
Related Therapeutic Areas
Sponsors
Leads: Koç University

This content was sourced from clinicaltrials.gov