Chemotherapy-induced Peripheral NeuropathyNCT06020222
The Effect of Cryotherapy on Breast Cancer Patients
A study testing cryotherapy and education in people with Chemotherapy-induced Peripheral Neuropathy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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?… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- cryotherapy and education
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Breast cancer stage I-III, first time receive paclitaxel neurotoxic chemotherapy, consciousness clear, able to communicate in Taiwanese or Mandarin
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tsai-Rung Lin
Kaohsiung City
Tsai Rung Lin, Master, 07-3121101 ext. 7481, 920410@kmuh.org.tw
Yun-Han Lee, Master
About this study
Official title: The Effect of Cryotherapy on Breast Cancer Patients in Kaohsiung Medical University Hospital
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.
Read the 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.
- Being tested
- cryotherapy, education
- Keywords
- breast cancer, chemotherapy, neuropathy, cryotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyDevice
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.
educationOther
Provide preventive CIPN education leaflets
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy group | Experimental | Both hands and feet received cryotherapy gloves and boots Receives: Device: cryotherapy |
| Usual care group | Placebo comparator | health education leaflets Receives: Other: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy, the Grade A to E, the higher the grade, the more serious
Measured: first day
Patient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
Measured: the day after the first chemotherapy
Patient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
Measured: the day after the second chemotherapy
Patient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
Measured: the day after the third chemotherapy
Patient neurotoxicity questionnaire (PNQ)
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
Measured: the day after the fourth chemotherapy
Secondary outcomes (15)
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
Measured: first day
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
Measured: the day after the first chemotherapy
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
Measured: the day after the second chemotherapy
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
Measured: the day after the third chemotherapy
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
Measured: the day after the fourth chemotherapy
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
Measured: first day
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
Measured: the day after the first chemotherapy
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
Measured: the day after the second chemotherapy
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
Measured: the day after the third chemotherapy
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
Measured: the day after the fourth chemotherapy
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher the score, the more severe the peripheal neuropathy
Measured: first day
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
Measured: the day after the first chemotherapy
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
Measured: the day after the second chemotherapy
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
Measured: the day after the third chemotherapy
TNSc(Total Neuropathy Score)
the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
Measured: the day after the fourth chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 May 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Nurses Association
- Responsible party
- Sponsor
- Investigators
- Tsai-Rung Lin, Master, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020222
- Sponsor's protocol ID
- KMUHIRB-F(I)-20230041
- Other IDs
- TWNA-1121020
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cryotherapy on Breast Cancer Patients in Kaohsiung Medical University Hospital
- ClinicalTrials.gov ID
- NCT06020222
- Acronym / sponsor ID
- KMUHIRB-F(I)-20230041
- Keywords
- breast cancer, chemotherapy, neuropathy, cryotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Taiwan Nurses Association
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy group | Experimental | Device: cryotherapyBoth hands and feet received cryotherapy gloves and boots |
| Usual care group | Placebo comparator | Other: educationhealth education leaflets |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Breast cancer stage I-III, first time receive paclitaxel neurotoxic chemotherapy, consciousness clear, able to communicate in Taiwanese or Mandarin
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapyBoth 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. | Device | Cryotherapy group |
| educationProvide preventive CIPN education leaflets | Other | Usual care group |
Primary outcome
Patient neurotoxicity questionnaire (PNQ)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
15 secondary outcomes
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
Time frame: first day
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
Time frame: the day after the first chemotherapy
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
Time frame: the day after the second chemotherapy
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
Time frame: the day after the third chemotherapy
European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
Time frame: the day after the fourth chemotherapy
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
Time frame: first day
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
Time frame: the day after the first chemotherapy
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
Time frame: the day after the second chemotherapy
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
Time frame: the day after the third chemotherapy
European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
Time frame: the day after the fourth chemotherapy
TNSc(Total Neuropathy Score)
Time frame: first day
TNSc(Total Neuropathy Score)
Time frame: the day after the first chemotherapy
TNSc(Total Neuropathy Score)
Time frame: the day after the second chemotherapy
TNSc(Total Neuropathy Score)
Time frame: the day after the third chemotherapy
TNSc(Total Neuropathy Score)
Time frame: the day after the fourth chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsai-Rung Lin, Master principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy and education in people with Chemotherapy-induced Peripheral Neuropathy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsai-Rung Lin, Master (07-31211014 ext. 7481, 920410@kmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient neurotoxicity questionnaire (PNQ) (time frame: first day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.