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临床试验/NCT06205173
NCT06205173已完成不适用

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

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life

时间窗: (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.

次要结局

  • The effectiveness of Cold and Hot Compress Nursing Interventions on the Symptoms 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)
  • The Effectiveness of Cold and Hot Compress Nursing Interventions on the Neurological Changes in the Hands and Feet.((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 Severity 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)
  • The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life and severity of Peripheral Neuropathy.((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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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