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临床试验/NCT05136573
NCT05136573Unknown不适用

Quality Association

Chi Mei Medical Hospital0 个研究点目标入组 20 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
主要终点
FACT/GOG

研究概览

简要总结

Objective:

Cancer is one of the biggest global health threats. The incidence and mortality of colorectal cancer (CRC) are increasing. The treatment of CRC is mainly surgical resection, and the standard treatment of metastatic colorectal cancer is Oxaliplatin chemotherapy, which is mainly a platinum agent (Alkylating agent). Oxaliplatin can exert its anti-cancer therapeutic effect by binding to cell DNA, and become toxic to neurons, damaging large and small fibers outside the brain and spinal cord. Causes peripheral neuropathy, which seriously affects the quality of life of patients. The purpose to develop the interventional and investigate intervention by exercise program of CRC patients with regard to the improvement effect of peripheral neuropathy, fatigue and quality of life during the treatment.

Methods:

Experimental study designs were used, and samples were taken from a regional teaching hospital. The control group received routine care and maintenance of general daily activities; the experimental group received routine care and maintenance of general daily activities, and also received combined exercises, balance training and resistance exercises twice a week, 60 minutes each time, plus weekly 5 walking exercises, 30 minutes each time, for a total of 12 weeks, of which the exercise training during chemotherapy and hospitalization is performed under the supervision of the investigator, and 1 balance training and resistance exercise are performed for 60 minutes each time to ensure that the patient performs. The correctness and safety of exercises, and balance training and resistance exercises in combination with the home style. During the home exercises, the researchers will give weekly telephone interviews to understand the patient's exercise status, and indeed achieve the balance training and resistance exercises twice a week. All measurement tools and methods are implemented in accordance with consistent standard operations. The control group took pre-tests when the case was closed, without interventional measures, but also performed post-tests in the same way as the experimental group at 6 weeks, 8 weeks, 10 weeks, and 12 weeks in the interventional experimental group.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with colon cancer, were getting chemotherapeutic drugs with oxaliplatin.

排除标准

  • bone metastasis, lower extremity lymphedema, cognitive dysfunction, musculoskeletal problems,and diabetic.

结局指标

主要结局

FACT/GOG

时间窗: 12 weeks

FACT/GOG-CIPN

EORTC QLQ-C30

时间窗: 12 weeks

qulity of life

次要结局

未报告次要终点

研究者

发起方
Chi Mei Medical Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chong-Chi Chiu

Center for quality management

Chi Mei Medical Hospital

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