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临床试验/NCT05873829
NCT05873829已完成不适用

The Effect of Hand-Foot Exercises on Platinum-Based Chemotheraphy Induced Peripheral Neuropathy Related Pain Severity, Falls and Quality of Life in Colorectal Cancer

Gulhane Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2022年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
2
主要终点
Chemotherapy Induced Peripheral Neuropathy Symptoms Assessment

研究概览

简要总结

Colorectal cancer is the 4th most common cancer in the world among all cancer types. Chemotherapy-induced peripheral neuropathy is a common and serious side effect caused by chemotherapeutic agents, especially platinum analogues, taxanes, vinca alkaloids and bortezomib. The most commonly used chemotherapeutic agents in the treatment of colorectal cancers are platinum analogues It is known that oxaliplatin, one of the platinum analogues, causes 85-96% of chemotherapy-induced peripheral neuropathy. The most common symptoms of chemotherapy-induced peripheral neuropathy are; numbness, paresthesia, dysesthesia, pain, hypersensitivity to cold or heat, tingling, muscle cramps, distal weakness, gait disturbances, balance disorders, and impaired movement. Oxaliplatin, which is frequently used in the treatment of colorectal cancer, causes symptoms of both acute and chronic chemotherapy-induced peripheral neuropathy. There is no proven method in the treatment of chemotherapy-induced peripheral neuropathy. However, various pharmacological and non-pharmacological approaches are applied in its preventive and symptomatic treatment. Exercise and physical therapy interventions; It is stated that it improves strength, balance and other functional disorders in patients, reduces symptoms, and reduces the risk of falling by affecting gross motor dysfunctions such as balance and gait abnormalities. However, the limitations of studies on this subject in the literature draw attention. This situation suggests that new methods that can be applied in the care of cancer patients who develop peripheral neuropathy due to chemotherapy should be developed in the field of nursing. This research is the first study to evaluate the effect of hand-foot exercises on colorectal cancer patients who developed peripheral neuropathy due to platinum-based therapy. Research results; Alleviation of KBPN-induced pain and prevention of falls are important in terms of increasing the quality of life of patients and providing evidence for nursing practices by using it as a new method that can be applied in the care of cancer patients with chemotherapy-induced peripheral neuropathy. The aim of this research was to determine the effect of hand-foot exercises on the severity of pain, falls and quality of life associated with platinum-based therapy-related peripheral neuropathy in patients with colorectal cancer.

详细描述

Aim of the study:This study was conducted to determine the effect of hand-foot exercises on platinum-based therapy-related peripheral neuropathy-related pain severity, falls and quality of life in patients with colorectal cancer.

Design of the study:The research is a randomized controlled experimental study conducted to determine the effect of hand-foot exercises on platinum-based therapy-related peripheral neuropathy-related pain severity, falls and quality of life in patients with colorectal cancer.

Study place and date:The research was carried out in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit. Research data were collected between 25 April and 31 December 2022.

Sample and setting:The population of the study consists of patients diagnosed with colorectal cancer who received platinum-based treatment in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit between April 25 and December 31, 2022. The sample of the study consists of patients who were diagnosed with colorectal cancer in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit between April 25 and December 31, 2022, received at least 2 and maximum 7 cycles of platinum-based chemotherapy and accepted to participate in the study.

Measuraments:Research data were collected with Sociodemographic and Clinical Characteristics Form, Exercise Follow-up Form, EORTC QLQ-C30 scale, EORTC QLQ-CR29 scale, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool, Numerical Pain Rating Scale, Fall Status Follow-up Form.

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
None

入排标准

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

入选标准

  • Being 18 years or older.
  • Not having any physical or mental health problems that will prevent communication.
  • Being conscious and cooperative.
  • Being diagnosed with colorectal cancer.
  • Receiving 2, 3, 4, 5, 6 or 7 cycles of platinum-based chemotherapy.
  • Being treated with the FOLFOX regimen.
  • Having chemotherapy-induced peripheral neuropathy according to CIPNAT (Chemotherapy-Induced Peripheral Neuropathy Assessment Tool). (Answering "yes" to the first 4 questions)
  • Agree to participate in the research.

排除标准

  • Receiving less than 2 cycles of platinum-based therapy.
  • To be receiving platinum-based treatment at 8th cycle and above.
  • Being diagnosed with a chronic disease (diabetes) that can lead to peripheral neuropathy.
  • Experiencing neuropathic symptoms due to cervical or lumbar hernia.
  • Having a habit of using alcohol constantly.
  • Being on medication that masks neuropathy signs or may develop neuropathy symptoms. (Opioid, beta blocker, anticonvulsant, tricyclic antidepressant etc.)
  • Having previously received neurotoxic chemotherapy (such as taxane, vinca alkaloids, bortezomib).
  • To have had major surgery in the last 1 month.
  • Not having the physical and mental ability to complete the research.
  • Refusing to participate in the research. Drop out Criteria
  • Changing the chemotherapy protocol.
  • Not being able to apply the Hand-Foot Exercises Program regularly.
  • Indicate that they want to withdraw from the research while the research is in progress.
  • Not being reached while the research is in progress.
  • Losing life while research is in progress.

结局指标

主要结局

Chemotherapy Induced Peripheral Neuropathy Symptoms Assessment

时间窗: 0. week (begining of the study) - 8. week (end of the study)

Hand-foot exercise program effects on chemotheraphy induced peripheral neuropathy symptoms- CIPNAT tool

Colorectal cancer patient's Quality of Life

时间窗: 0. week (begining of the study) - 8. week (end of the study)

Hand-foot exercise program effects on quality of life of patients-EORTC QLQ-C30, EORTC QLQ-CR29 scales

Chemotheraphy induced peripheral neuropaty related Pain Severity

时间窗: 0. week (begining of the study) - 8. week (end of the study)

Hand-foot exercise program effects on platiunum based chemotheraphy induced peripheral neuropathy related pain severtiy- Numeric Pain Rating Scale

Chemotheraphy induced peripheral neuropaty related Falls

时间窗: 0. week (begining of the study) - 8. week (end of the study)

Hand-foot exercise program effects on platiunum based chemotheraphy induced peripheral neuropathy related falls-Fall Follow-up Form

次要结局

未报告次要终点

研究者

发起方
Gulhane Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

İlayda EROĞLU

Research Assistant

Gulhane Training and Research Hospital

研究点 (2)

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