Clinical trial NCT06020222: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: breast cancer
chemotherapy
neuropathy
cryotherapy
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Taiwan Nurses Association
First posted: 2023-08-31
Enrollment: 94
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Patient neurotoxicity questionnaire (PNQ)
timeFrame: first day
measure: Patient neurotoxicity questionnaire (PNQ)
timeFrame: the day after the first chemotherapy
measure: Patient neurotoxicity questionnaire (PNQ)
timeFrame: the day after the second chemotherapy
measure: Patient neurotoxicity questionnaire (PNQ)
timeFrame: the day after the third chemotherapy
measure: Patient neurotoxicity questionnaire (PNQ)
timeFrame: the day after the fourth chemotherapy
Secondary outcomes:
measure: European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
timeFrame: first day
measure: European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
timeFrame: the day after the first chemotherapy
measure: European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
timeFrame: the day after the second chemotherapy
measure: European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
timeFrame: the day after the third chemotherapy
measure: European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
timeFrame: the day after the fourth chemotherapy
measure: European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
timeFrame: first day
measure: European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
timeFrame: the day after the first chemotherapy
measure: European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
timeFrame: the day after the second chemotherapy
measure: European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
timeFrame: the day after the third chemotherapy
measure: European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
timeFrame: the day after the fourth chemotherapy
measure: TNSc(Total Neuropathy Score)
timeFrame: first day
measure: TNSc(Total Neuropathy Score)
timeFrame: the day after the first chemotherapy
measure: TNSc(Total Neuropathy Score)
timeFrame: the day after the second chemotherapy
measure: TNSc(Total Neuropathy Score)
timeFrame: the day after the third chemotherapy
measure: TNSc(Total Neuropathy Score)
timeFrame: the day after the fourth chemotherapy
Other outcomes:
measure: the adverse event and discomfort
timeFrame: the day after the first cryotherapy
measure: the adverse event and discomfort
timeFrame: the day after the second cryotherapy
measure: the adverse event and discomfort
timeFrame: the day after the third cryotherapy
measure: the adverse event and discomfort
timeFrame: the day after the fourth cryotherapy
Locations:
city: Kaohsiung
country: Taiwan
facility: Tsai-Rung Lin
Study officials:
affiliation: Kaohsiung Medical University
name: Tsai-Rung Lin, Master
role: PRINCIPAL_INVESTIGATOR
References: