The Effect of Cryotherapy on Breast Cancer Patients

Not Applicable

Recruiting

• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Interventions: Device: cryotherapy; Other: education

• Registration Number: NCT06020222
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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.

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-01
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-08-27
• Last Update Submitted: 2023-08-27
• Study First Posted: 2023-08-31
• Last Update Posted: 2023-08-31
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

• Clinical diagnosis of Breast cancer stage I-III, first time receive paclitaxel neurotoxic chemotherapy, consciousness clear, able to communicate in Taiwanese or Mandarin

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Exclusion Criteria

• Insulin depent diabetes, Raynaud's disease, cold urticaria disease, cryoglobulinemia and sclerosing basal cell carcinoma, those diagnosed with mental illness, and those with visual or hearing impairments.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy group	cryotherapy	Both hands and feet received cryotherapy gloves and boots
Usual care group	education	health education leaflets

Primary Outcome Measures

Name	Time	Method
Patient neurotoxicity questionnaire (PNQ)	the day after the fourth chemotherapy	the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious

Secondary Outcome Measures

Name	Time	Method
TNSc(Total Neuropathy Score)	the day after the fourth chemotherapy	the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20	the day after the fourth chemotherapy	the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30	the day after the fourth chemotherapy	the quality of life in breast cancer patients,higher score indicate pooer quality of life

Trial Locations

Locations (1)

Tsai-Rung Lin; 🇨🇳 Kaohsiung, Taiwan