NCT06020222

The Effect of Cryotherapy on Breast Cancer Patients

The Effect of Cryotherapy on Breast Cancer Patients in Kaohsiung Medical University Hospital

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test the effect of cryotherpay on chemotherapy-induced peripheral neuropathy(CIPN) among Breast Cancer Patients. The main questions of research are: * Does cryotherapy reduce the incidence of CIPN? * Does cryotherapy reduce the severity of CIPN and improve the quality of life? Participants will be put on the cold gloves and boots during chemotherapy injection process and total 90 minutes. If there is a comparison group: Researchers will compare usual care group to make sure if it effects of CIPN.

Detailed description

This study is designed as a experiment study. In a medical center and breast ward, a randomized controlled trial was used to evaluate the effect of cryotherapy. Block sampling was adopted, and participants total 94 were included. Patients were randomly assigned to the croytherapy group (n=47) or the usual care group(n=47). Both hands and feet received cryotherapy, and the frequency was once every three weeks. Each cycle was 90-150 minutes, and the cycle was performed 4-8 times. The instrument included EPRTC QLQ-CIPN20, PNQ, and EORTC QLQ-C30. After 12-32 weeks, the cryotherapy received qualitative interviews to collect experience and perceptions. Quantitaitve data were constructed and analyzed with SPSS 20.0 version, and Chi-square test was used to detect the incidence of CIPN after three months. Mixed linear model was used to detect the severity of peripheral neuropathy symptoms and quality of life. Survival analysis was used to compare the occurrence time of peripheral neuropathy events between groups.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	cryotherapy	Both hands and feet received cryotherapy gloves and boots, and the frequency was once every three weeks. Each cycle was 90 minutes, and the cycle was performed 4 times.
OTHER	education	Provide preventive CIPN education leaflets

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-10-01
• Completion: 2024-12-31
• First posted: 2023-08-31
• Last updated: 2023-08-31

Locations

1 site across 1 country: Taiwan