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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
94
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.
Provide preventive CIPN education leaflets
Tsai-Rung Lin
Kaohsiung City, Taiwan
RECRUITINGPatient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy, the Grade A to E, the higher the grade, the more serious
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: the day after the fourth 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: first day
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: the day after the fourth chemotherapy