The Effect of Cryotherapy on Breast Cancer Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Device: cryotherapy
* Other: education


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryotherapy group<br>Both hands and feet received cryotherapy gloves and boots | Device: cryotherapy<br>* 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.<br>|
| Placebo Comparator: Usual care group<br>health education leaflets | Other: education<br>* Provide preventive CIPN education leaflets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient neurotoxicity questionnaire (PNQ) | the incidence of sensory and motor neuropathy, the Grade A to E, the higher the grade, the more serious | first day | 
| Patient neurotoxicity questionnaire (PNQ) | the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious | the day after the first chemotherapy | 
| Patient neurotoxicity questionnaire (PNQ) | the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious | the day after the second chemotherapy | 
| Patient neurotoxicity questionnaire (PNQ) | the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious | the day after the third chemotherapy | 
| Patient neurotoxicity questionnaire (PNQ) | the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious | the day after the fourth chemotherapy | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, chemotherapy, neuropathy, cryotherapy