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| ID | Type | Description | Link |
|---|---|---|---|
| TWNA-1121020 | Other Grant/Funding Number | Funder |
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| Name | Class |
|---|---|
| Taiwan Nurses Association | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryotherapy group | Experimental | Both hands and feet received cryotherapy gloves and boots |
|
| Usual care group | Placebo Comparator | health education leaflets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryotherapy | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the adverse event and discomfort | the incidence of adverse event and discomfort during cryotherapy | the day after the first cryotherapy |
| the adverse event and discomfort | the incidence of adverse event and discomfort during cryotherapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tsai-Rung Lin, Master | Contact | 07-31211014 | 7481 | 920410@kmuh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Tsai-Rung Lin, Master | Kaohsiung Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tsai-Rung Lin | Recruiting | Kaohsiung City | Taiwan |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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Assessors don't know groups
| education | Other | Provide preventive CIPN education leaflets |
|
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 |
| the day after the second cryotherapy |
| the adverse event and discomfort | the incidence of adverse event and discomfort during cryotherapy, the more times, the more frequent side effect | the day after the third cryotherapy |
| the adverse event and discomfort | the incidence of adverse event and discomfort during cryotherapy,the more times, the more frequent side effect | the day after the fourth cryotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |