NCT05138042

Chemotherapy - Induced Peripheral Neuropathy

Effect of Cryotherapy on Paclitaxel-Induced Peripheral Neuropathy of the Hand in Female Breast Cancer Patients: A Prospective Self-Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to examine the efficacy of cryotherapy with frozen gloves for the prevention of the chemotherapy-induced peripheral neuropathy (CIPN) of the hand. Frozen glove was provided for dominant hand of breast cancer patients while receiving paclitaxel treat, and as the experimental group. In addition, another hand as a control group. The questionnaire was used before chemotherapy and at the fourth, eighth, twelfth, and sixteenth weeks to understand the effectiveness of frozen gloves.

Detailed description

In this study, the cryotherapy interventions were based on previous studies, with the dominant hand wearing the frozen glove set as the experimental group, and the non-dominant hand that was not wearing a frozen glove as the control group. The Elasto-Gel flexible frozen glove (Southwest Technologies, North Kansas City, MO, USA) used in this study lasted for 20 to 40 minutes and was easy to clean.The cold temperature of the refrigerator was measured in advance to be -20.2°C to -22.8°C. The freezing of the gloves lasted for at least three hours, and the gloves were tested with an infrared temperature-measuring instrument before use. Its temperature range was -24.3°C to -24.7°C. The patient began to wear gloves 15 minutes before the administration of paclitaxel for one hour, and replaced them with new frozen gloves at the 45th minute. The patient continued to wear the gloves until 15 minutes after the end of the chemotherapy drug administration, for a total of 90 minutes. These intervention procedures were used for each treatment for 12 weeks.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
OTHER	Cryotherapy (frozen glove)	In this study, the cryotherapy interventions were based on previous studies, with the dominant hand wearing the frozen glove set as the experimental group, and the non-dominant hand that was not wearing a frozen glove as the control group. The cold temperature of the refrigerator was measured in advance to be -20.2°C to -22.8°C. The freezing of the gloves lasted for at least three hours, and the gloves were tested with an infrared temperature-measuring instrument before use. Its temperature range was -24.3°C to -24.7°C. The patient began to wear gloves 15 minutes before the administration of paclitaxel for one hour, and replaced them with new frozen gloves at the 45th minute. The patient continued to wear the gloves until 15 minutes after the end of the chemotherapy drug administration, for a total of 90 minutes.

Timeline

• Start date: 2019-10-01
• Primary completion: 2019-10-07
• Completion: 2020-10-15
• First posted: 2021-11-30
• Last updated: 2021-11-30

Locations

1 site across 1 country: Taiwan