Colorectal CancerNCT06205173
Explored About Temperature Packing Care to Improve the Quality of Life for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colorectal Cancer and Gastric Cancer Patient
A study testing Hot compressing and Cold compressing in people with Colorectal Cancer and Gastric Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Investigate the effectiveness of cold and hot compress interventions in reducing peripheral neuropathy induced by Oxaliplatin chemotherapy in colorectal cancer and gastric cancer patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer, Gastric Cancer, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Hot compressing and Cold compressing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Aug 2020to 30 Aug 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 20 and above, inclusive, can autonomously decide to participate in this study and complete the Participant Consent Form.
- Patients diagnosed with colorectal cancer, receiving chemotherapy for the first time, and being prescribed the standard FOLFOX regimen with Oxaliplatin as the primary agent are eligible. The dosage is 85mg/m2 administered over a 2-hour injection every 14 days, constituting one treatment cycle. A total of 6 treatment cycles will be conducted.
Who cannot join
- Individuals with an undiagnosed medical condition.
- Individuals with thyroid disorders, diabetes, undergoing dialysis, pregnant, alcohol abusers, and those with immune-related diseases such as lupus erythematosus, scleroderma, dermatomyositis, and rheumatoid arthritis are excluded from the study..
- Individuals with defects in hands, feet, or fingers.
Trial locations and contacts
1 site in 1 country.
About this study
Investigate the effectiveness of cold and hot compress interventions in reducing peripheral neuropathy induced by Oxaliplatin chemotherapy in colorectal cancer and gastric cancer patients. The primary outcome measures include quality of life, and secondary outcome measures encompass the severity of peripheral neuropathy, manual dexterity assessed through finger strength testing, and the effects on microcirculation blood flow in the hands and feet
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in cancer patients undergoing chemotherapy, with an overall incidence rate of approximately 70-100% for Oxaliplatin. The symptomatology typically manifests as a "glove and stocking" neuropathy, leading to sensory abnormalities that significantly impact patients' activities of daily living and reduce their overall quality of life. Furthermore, it may result in dosage reduction, treatment delays, or interruptions. Studies indicate that residual symptoms persist in 68.1% of patients one month after the completion of chemotherapy, emphasizing the long-term effects of CIPN on post-treatment individuals. Consequently, there is a pressing need for evidence-based preventive intervention research.
- Being tested
- Hot compressing, Cold compressing
- Keywords
- Hot compressing, Colon Cancer, Colorectal Cancer, Chemotherapy-induced Peripheral Neuropathy, Gastric Cancer
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot compressingOther
The intervention in this study will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. Throughout the process, the patient's local site will be checked every 15 minutes for signs of redness, abnormal sensations, and skin temperature measurement to assess potential harm caused by the applied temperature. If any adverse reactions occur, the intervention will be stopped as necessary.
Cold compressingOther
The intervention in this study will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. Throughout the process, the patient's local site will be checked every 15 minutes for signs of redness, abnormal sensations, and skin temperature measurement to assess potential harm caused by the applied temperature. If any adverse reactions occur, the intervention will be stopped as necessary.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | According to the traditional care model, no interventions are applied to the hands and feet. |
| Hot compressing group | Experimental | Temperature control will be maintained within the range of 37-38 degrees Celsius.The application will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. Receives: Other: Cold compressing |
| Cold compressing group | Experimental | Temperature control will be maintained within the range of 12-18 degrees Celsius.The application will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. Receives: Other: Hot compressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life
Quality of Life was measured by EORTC-QLQ-C30.The scale assesses symptoms, functionality, and overall health status/life quality. Each item is transformed to a 0-100 scale according to a standardized scoring procedure.Higher scores indicate more severe symptoms, while in the functionality and overall health status/life quality sections, higher scores signify better conditions.
Measured: (1) Before the initiation of the first chemotherapy session. (2) Before the 6th administration of chemotherapy drugs. (3) Before the 12th administration of chemotherapy drugs. (4) Within three months after the completion of the chemotherapy course.
Secondary outcomes (4)
The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life and severity of Peripheral Neuropathy.
Severity of Peripheral Neuropathy was measured by EORTC QLQ-CIPN2. This assesses symptoms and functional limitations related to sensory, motor, and autonomic nervous system disorders.Each item is transformed to a 0-100 scale according to a standardized scoring procedure.Higher scores indicate more severe symptoms, while in the functionality and overall health status/life quality sections, higher scores signify better conditions.
Measured: (1) Before the initiation of the first chemotherapy session. (2) Before each administration of chemotherapy drugs (total of 12 times). (3) Within three months after the completion of the chemotherapy course.
The effectiveness of Cold and Hot Compress Nursing Interventions on the Severity of Peripheral Neuropathy.
Severity of Peripheral Neuropathy was measured by Total Neuropathy Score-clinical.The assessment includes 3 subjective symptom and 4 objective evaluations, which encompass muscle strength, deep tendon reflexes, vibration threshold, and pinprick sensation. Scores range from 0 (no neuropathy) to 4 (severe neuropathy), higher total score indicating a higher degree of peripheral neuropathy.
Measured: (1) before the initiation of Oxaliplatin treatment, (2)after the completion of the 6th injection until the start of the 7th injection (approximately three months into chemotherapy), (3)Within three months after the completion of the chemotherapy course
The effectiveness of Cold and Hot Compress Nursing Interventions on the Symptoms of Peripheral Neuropathy.
Severity of Peripheral Neuropathy was measured by NCI-CTCAE. Includes evaluations of both motor and sensory nerves. The NCI-CTCAE is primarily based on the severity of adverse events and utilizes a grading system ranging from one (mild) to five (death) to characterize the extent of events. A higher grade indicates more severe symptoms.
Measured: (1) before the initiation of Oxaliplatin treatment, (2)after the completion of the 6th injection until the start of the 7th injection (approximately three months into chemotherapy), (3)Within three months after the completion of the chemotherapy course
The Effectiveness of Cold and Hot Compress Nursing Interventions on the Neurological Changes in the Hands and Feet.
The Effectiveness of Cold and Hot Compress Nursing Interventions on the Neurological Changes in the Hands and Feet through Neuro- electro-physiological study which including upper and lower limb motor nerve conduction measurements, sensory nerve conduction velocity measurements, and F-wave measurements.These were measured by Rehabilitation Physician.
Measured: (1) before the initiation of Oxaliplatin treatment, (2)after the completion of the 6th injection until the start of the 7th injection (approximately three months into chemotherapy), (3)Within three months after the completion of the chemotherapy course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start19 Aug 2020
- Primary completion9 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205173
- Sponsor's protocol ID
- 201909032RINA
- Status last verified
- Nov 2023
- First submitted
- 24 Nov 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explored About Temperature Packing Care to Improve the Quality of Life for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colorectal Cancer and Gastric Cancer Patient
- ClinicalTrials.gov ID
- NCT06205173
- Acronym / sponsor ID
- 201909032RINA
- Keywords
- Hot compressing, Colon Cancer, Colorectal Cancer, Chemotherapy-induced Peripheral Neuropathy, Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 12 Jan 2024 (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.
Investigate the effectiveness of cold and hot compress interventions in reducing peripheral neuropathy induced by Oxaliplatin chemotherapy in colorectal cancer and gastric cancer patients. The primary outcome measures include quality of life, and secondary outcome measures encompass the severity of peripheral neuropathy, manual dexterity assessed through finger strength testing, and the effects on microcirculation blood flow in the hands and feet
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in cancer patients undergoing chemotherapy, with an overall incidence rate of approximately 70-100% for Oxaliplatin. The symptomatology typically manifests as a "glove and stocking" neuropathy, leading to sensory abnormalities that significantly impact patients' activities of daily living and reduce their overall quality of life. Furthermore, it may result in dosage reduction, treatment delays, or interruptions. Studies indicate that residual symptoms persist in 68.1% of patients one month after the completion of chemotherapy, emphasizing the long-term effects of CIPN on post-treatment individuals. Consequently, there is a pressing need for evidence-based preventive intervention research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –According to the traditional care model, no interventions are applied to the hands and feet. |
| Hot compressing group | Experimental | Other: Cold compressingTemperature control will be maintained within the range of 37-38 degrees Celsius.The application will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. |
| Cold compressing group | Experimental | Other: Hot compressingTemperature control will be maintained within the range of 12-18 degrees Celsius.The application will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals aged 20 and above, inclusive, can autonomously decide to participate in this study and complete the Participant Consent Form.
- Patients diagnosed with colorectal cancer, receiving chemotherapy for the first time, and being prescribed the standard FOLFOX regimen with Oxaliplatin as the primary agent are eligible. The dosage is 85mg/m2 administered over a 2-hour injection every 14 days, constituting one treatment cycle. A total of 6 treatment cycles will be conducted.
Key exclusion criteria (3 listed)
- Individuals with an undiagnosed medical condition.
- Individuals with thyroid disorders, diabetes, undergoing dialysis, pregnant, alcohol abusers, and those with immune-related diseases such as lupus erythematosus, scleroderma, dermatomyositis, and rheumatoid arthritis are excluded from the study..
- Individuals with defects in hands, feet, or fingers.
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 |
|---|---|---|
| Hot compressingThe intervention in this study will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. Throughout the process, the patient's local site will be checked every 15 minutes for signs of redness, abnormal sensations, and skin temperature measurement to assess potential harm caused by the applied temperature. If any adverse reactions occur, the intervention will be stopped as necessary. | Other | Cold compressing group |
| Cold compressingThe intervention in this study will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. Throughout the process, the patient's local site will be checked every 15 minutes for signs of redness, abnormal sensations, and skin temperature measurement to assess potential harm caused by the applied temperature. If any adverse reactions occur, the intervention will be stopped as necessary. | Other | Hot compressing group |
Primary outcome
The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life
Time frame: (1) Before the initiation of the first chemotherapy session. (2) Before the 6th administration of chemotherapy drugs. (3) Before the 12th administration of chemotherapy drugs. (4) Within three months after the completion of the chemotherapy course.
Quality of Life was measured by EORTC-QLQ-C30.The scale assesses symptoms, functionality, and overall health status/life quality. Each item is transformed to a 0-100 scale according to a standardized scoring procedure.Higher scores indicate more severe symptoms, while in the functionality and overall health status/life quality sections, higher scores signify better conditions.
4 secondary outcomes
The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life and severity of Peripheral Neuropathy.
Time frame: (1) Before the initiation of the first chemotherapy session. (2) Before each administration of chemotherapy drugs (total of 12 times). (3) Within three months after the completion of the chemotherapy course.
The effectiveness of Cold and Hot Compress Nursing Interventions on the Severity of Peripheral Neuropathy.
Time frame: (1) before the initiation of Oxaliplatin treatment, (2)after the completion of the 6th injection until the start of the 7th injection (approximately three months into chemotherapy), (3)Within three months after the completion of the chemotherapy course
The effectiveness of Cold and Hot Compress Nursing Interventions on the Symptoms of Peripheral Neuropathy.
Time frame: (1) before the initiation of Oxaliplatin treatment, (2)after the completion of the 6th injection until the start of the 7th injection (approximately three months into chemotherapy), (3)Within three months after the completion of the chemotherapy course
The Effectiveness of Cold and Hot Compress Nursing Interventions on the Neurological Changes in the Hands and Feet.
Time frame: (1) before the initiation of Oxaliplatin treatment, (2)after the completion of the 6th injection until the start of the 7th injection (approximately three months into chemotherapy), (3)Within three months after the completion of the chemotherapy course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot compressing and Cold compressing in people with Colorectal Cancer and Gastric Cancer, run by National Taiwan University 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 12 Jan 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life (time frame: (1) Before the initiation of the first chemotherapy session. (2) Before the 6th administration of chemotherapy drugs. (3) Before the 12th administration of chemotherapy drugs. (4) Within three months after the completion of the chemotherapy course.). 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 12 Jan 2024; AzTrials last refreshed its copy on 5 Nov 2026.