Clinical trial NCT06205173: Explored About Temperature Packing Care to Improve the Quality of Life for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colorectal Cancer and Gastric Cancer Patient
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Gastric Cancer
Chemotherapy-induced Peripheral Neuropathy
Keywords: Hot compressing
Colon Cancer
Colorectal Cancer
Chemotherapy-induced Peripheral Neuropathy
Gastric Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life
timeFrame: (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:
measure: The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life and severity of Peripheral Neuropathy.
timeFrame: (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.
measure: The effectiveness of Cold and Hot Compress Nursing Interventions on the Severity of Peripheral Neuropathy.
timeFrame: (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
measure: The effectiveness of Cold and Hot Compress Nursing Interventions on the Symptoms of Peripheral Neuropathy.
timeFrame: (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
measure: The Effectiveness of Cold and Hot Compress Nursing Interventions on the Neurological Changes in the Hands and Feet.
timeFrame: (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
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: