The Effect of Cryotherapy on Breast Cancer Patients
Study Details
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:
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Does cryotherapy reduce the incidence of CIPN?
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cryotherapy group Both hands and feet received cryotherapy gloves and boots |
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.
|
| Placebo Comparator: Usual care group health education leaflets |
Other: education
Provide preventive CIPN education leaflets
|
Outcome Measures
Primary Outcome Measures
- 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
- Patient neurotoxicity questionnaire (PNQ) [the day after the first chemotherapy]
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
- Patient neurotoxicity questionnaire (PNQ) [the day after the second chemotherapy]
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
- Patient neurotoxicity questionnaire (PNQ) [the day after the third chemotherapy]
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
- Patient neurotoxicity questionnaire (PNQ) [the day after the fourth chemotherapy]
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 [first day]
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 day after the first chemotherapy]
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 day after the second chemotherapy]
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 day after the third chemotherapy]
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 day after the fourth chemotherapy]
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
- European Organization for the Research and Treatment of Cancer core questionnaire QLQ30 [the day after the first chemotherapy]
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 day after the second chemotherapy]
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 day after the third chemotherapy]
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 day after the fourth chemotherapy]
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
- TNSc(Total Neuropathy Score) [the day after the first chemotherapy]
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
- TNSc(Total Neuropathy Score) [the day after the second chemotherapy]
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
- TNSc(Total Neuropathy Score) [the day after the third chemotherapy]
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
- TNSc(Total Neuropathy Score) [the day after the fourth chemotherapy]
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
Other Outcome Measures
- the adverse event and discomfort [the day after the first cryotherapy]
the incidence of adverse event and discomfort during cryotherapy
- the adverse event and discomfort [the day after the second cryotherapy]
the incidence of adverse event and discomfort during cryotherapy
- the adverse event and discomfort [the day after the third cryotherapy]
the incidence of adverse event and discomfort during cryotherapy, the more times, the more frequent side effect
- the adverse event and discomfort [the day after the fourth cryotherapy]
the incidence of adverse event and discomfort during cryotherapy,the more times, the more frequent side effect
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tsai-Rung Lin | Kaohsiung | Taiwan |
Sponsors and Collaborators
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Taiwan Nurses Association
Investigators
- Principal Investigator: Tsai-Rung Lin, Master, Kaohsiung Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KMUHIRB-F(I)-20230041
- TWNA-1121020