Chemotherapy-induced Peripheral Neuropathy
Conditions
Keywords
breast cancer, chemotherapy, neuropathy, cryotherapy
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.
Interventions
DEVICEcryotherapy
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.
OTHEReducation
Provide preventive CIPN education leaflets
Sponsors
Taiwan Nurses Association
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
Assessors don't know groups
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient neurotoxicity questionnaire (PNQ) | first day | the incidence of sensory and motor neuropathy, the Grade A to E, the higher the grade, the more serious |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20 | first day | 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 | first day | the quality of life in breast cancer patients, higher score indicate pooer quality of life |
| TNSc(Total Neuropathy Score) | first day | the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher the score, the more severe the peripheal neuropathy |
Other
| Measure | Time frame | Description |
|---|---|---|
| the adverse event and discomfort | the day after the first cryotherapy | the incidence of adverse event and discomfort during cryotherapy |
Countries
Taiwan
Contacts
Primary ContactTsai-Rung Lin, Master
Outcome results
None listed