Explored About Temperature Packing Care to Improve the Quality of Life for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colorectal Cancer and Gastric Cancer Patient

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06205173
• Other study ID #: 201909032RINA
• Status: Completed
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: November 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 30, 2021
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Colorectal Cancer
• Colorectal Neoplasms
• Gastric Cancer
• Peripheral Nervous System Diseases
• Stomach Neoplasms

Intervention

Other:
• Hot compressing
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 compressing
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	(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	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.	(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.
Secondary	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.	(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
Secondary	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.	(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
Secondary	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.	(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