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Trial Title:
The Effect of Cryotherapy on Breast Cancer Patients
NCT ID:
NCT06020222
Condition:
Chemotherapy-induced Peripheral Neuropathy
Conditions: Official terms:
Peripheral Nervous System Diseases
Conditions: Keywords:
breast cancer
chemotherapy
neuropathy
cryotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Investigator)
Masking description:
Assessors don't know groups
Intervention:
Intervention type:
Device
Intervention name:
cryotherapy
Description:
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.
Arm group label:
Cryotherapy group
Intervention type:
Other
Intervention name:
education
Description:
Provide preventive CIPN education leaflets
Arm group label:
Usual care group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tsai-Rung Lin
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Tsai Rung Lin, Master
Phone:
07-3121101
Phone ext:
7481
Email:
920410@kmuh.org.tw
Investigator:
Last name:
Yun-Han Lee, Master
Email:
Sub-Investigator
Investigator:
Last name:
Yu-Ying Huang, Master
Email:
Sub-Investigator
Investigator:
Last name:
Hsin-Tien Hsu, Phd
Email:
Sub-Investigator
Start date:
May 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
Taiwan Nurses Association
Agency class:
Other
Source:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06020222
