The Effect of Cryotherapy on Breast Cancer Patients

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

The Effect of Cryotherapy on Breast Cancer Patients in Kaohsiung Medical University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020222
• Other study ID #: KMUHIRB-F(I)-20230041
• Secondary ID: TWNA-1121020
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Tsai-Rung Lin, Master
• Phone: 07-31211014
• Email: 920410[@]kmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Device:
• cryotherapy
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.

Other:
• education
Provide preventive CIPN education leaflets

Locations

Country	Name	City	State
Taiwan	Tsai-Rung Lin	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Taiwan Nurses Association

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the adverse event and discomfort	the incidence of adverse event and discomfort during cryotherapy	the day after the first cryotherapy
Other	the adverse event and discomfort	the incidence of adverse event and discomfort during cryotherapy	the day after the second cryotherapy
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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 first chemotherapy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	TNSc(Total Neuropathy Score)	the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher the score, the more severe the peripheal neuropathy	first day
Secondary	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
Secondary	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
Secondary	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
Secondary	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