Cold therapy for treating peripheral neuropathy in children with cancer
The Effect of Cold Therapy on Peripheral Neuropathy: A Pilot Randomized Controlled Trial
This study tests if using cold therapy gloves and socks can help children with cancer who are experiencing nerve pain from their treatment feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 7 Years to 18 Years |
| Sex | All |
| Sponsor | Koç University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06488963 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility, acceptability, and efficacy of cold therapy using NatraCure gloves and socks to alleviate vincristine-induced peripheral neuropathy (VIPN) in pediatric cancer patients aged 7-18. The research focuses on children diagnosed with specific types of leukemia and tumors who are undergoing vincristine chemotherapy. By assessing the impact of cold therapy on reducing neuropathy symptoms and improving quality of life, the study aims to provide a potential management strategy for this common side effect of cancer treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 7-18 years who are receiving vincristine therapy and have been diagnosed with leukemia, medulloblastoma, rhabdomyosarcoma, or Wilms tumor.
Not a fit: Patients who have a history of peripheral neuropathy, diabetes, or self-reported cold sensitivity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve the quality of life for children suffering from VIPN.
How similar studies have performed: While there is limited research specifically on cold therapy for VIPN, the approach of using cold treatment for neuropathy has shown promise in other contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: Risk factors for peripheral neuropathy were considered exclusion criteria. Risk factor criteria were: * 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.
Where this trial is running
Istanbul
- Koc University — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Eyşan Hanzade Umaç
- Email: euma14@ku.edu.tr
- Phone: 506848841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.