The Effect of Cryotherapy on Breast Cancer Patients
Primary Purpose
Chemotherapy-induced Peripheral Neuropathy
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cryotherapy
education
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring breast cancer, chemotherapy, neuropathy, cryotherapy
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.
Sites / Locations
- Tsai-Rung LinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cryotherapy group
Usual care group
Arm Description
Both hands and feet received cryotherapy gloves and boots
health education leaflets
Outcomes
Primary Outcome Measures
Patient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy, the Grade A to E, the higher the grade, the more serious
Patient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
Patient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
Patient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
Patient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher the score, the more severe the peripheal neuropathy
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
Full Information
NCT ID
NCT06020222
First Posted
May 2, 2023
Last Updated
August 27, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Taiwan Nurses Association
1. Study Identification
Unique Protocol Identification Number
NCT06020222
Brief Title
The Effect of Cryotherapy on Breast Cancer Patients
Official Title
The Effect of Cryotherapy on Breast Cancer Patients in Kaohsiung Medical University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Taiwan Nurses Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy
Keywords
breast cancer, chemotherapy, neuropathy, cryotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Assessors don't know groups
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryotherapy group
Arm Type
Experimental
Arm Description
Both hands and feet received cryotherapy gloves and boots
Arm Title
Usual care group
Arm Type
Placebo Comparator
Arm Description
health education leaflets
Intervention Type
Device
Intervention Name(s)
cryotherapy
Intervention 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.
Intervention Type
Other
Intervention Name(s)
education
Intervention Description
Provide preventive CIPN education leaflets
Primary Outcome Measure Information:
Title
Patient neurotoxicity questionnaire (PNQ)
Description
the incidence of sensory and motor neuropathy, the Grade A to E, the higher the grade, the more serious
Time Frame
first day
Title
Patient neurotoxicity questionnaire (PNQ)
Description
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
Title
Patient neurotoxicity questionnaire (PNQ)
Description
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
Title
Patient neurotoxicity questionnaire (PNQ)
Description
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
Title
Patient neurotoxicity questionnaire (PNQ)
Description
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
Secondary Outcome Measure Information:
Title
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
Description
the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
Time Frame
first day
Title
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
Description
the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
Time Frame
the day after the first chemotherapy
Title
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
Description
the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
Time Frame
the day after the second chemotherapy
Title
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
Description
the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
Time Frame
the day after the third chemotherapy
Title
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
Description
the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
Time Frame
the day after the fourth chemotherapy
Title
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
Description
the quality of life in breast cancer patients, higher score indicate pooer quality of life
Time Frame
first day
Title
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
Description
the quality of life in breast cancer patients,higher score indicate pooer quality of life
Time Frame
the day after the first chemotherapy
Title
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
Description
the quality of life in breast cancer patients,higher score indicate pooer quality of life
Time Frame
the day after the second chemotherapy
Title
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
Description
the quality of life in breast cancer patients,higher score indicate pooer quality of life
Time Frame
the day after the third chemotherapy
Title
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
Description
the quality of life in breast cancer patients,higher score indicate pooer quality of life
Time Frame
the day after the fourth chemotherapy
Title
TNSc(Total Neuropathy Score)
Description
the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher the score, the more severe the peripheal neuropathy
Time Frame
first day
Title
TNSc(Total Neuropathy Score)
Description
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
Title
TNSc(Total Neuropathy Score)
Description
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
Title
TNSc(Total Neuropathy Score)
Description
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
Title
TNSc(Total Neuropathy Score)
Description
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
Other Pre-specified Outcome Measures:
Title
the adverse event and discomfort
Description
the incidence of adverse event and discomfort during cryotherapy
Time Frame
the day after the first cryotherapy
Title
the adverse event and discomfort
Description
the incidence of adverse event and discomfort during cryotherapy
Time Frame
the day after the second cryotherapy
Title
the adverse event and discomfort
Description
the incidence of adverse event and discomfort during cryotherapy, the more times, the more frequent side effect
Time Frame
the day after the third cryotherapy
Title
the adverse event and discomfort
Description
the incidence of adverse event and discomfort during cryotherapy,the more times, the more frequent side effect
Time Frame
the day after the fourth cryotherapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsai-Rung Lin, Master
Phone
07-31211014
Ext
7481
Email
920410@kmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsai-Rung Lin, Master
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tsai-Rung Lin
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsai Rung Lin, Master
Phone
07-3121101
Ext
7481
Email
920410@kmuh.org.tw
First Name & Middle Initial & Last Name & Degree
Yun-Han Lee, Master
First Name & Middle Initial & Last Name & Degree
Yu-Ying Huang, Master
First Name & Middle Initial & Last Name & Degree
Hsin-Tien Hsu, Phd
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Cryotherapy on Breast Cancer Patients
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