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临床试验/NCT04799080
NCT04799080已完成不适用

Investigation of the Effect of Chemotherapy-induced Peripheral Neuropathy (CIPN) on Sensory and Motor Function in Patients With Cancer

Izmir Bakircay University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年3月6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
72
试验地点
1
主要终点
Hand Grip Strength

研究概览

简要总结

As cancer survival rates have been increased due to technological developments and early detection strategies, there has been been a growing need to assess the effect of long-term complications and adverse effects upon patients' functionality and quality of life. Chemotherapy, which is accepted to be the body of systemic adjuvant therapy is attributed to long-term survival, yet some side effects such as sarcopenia, loss of muscle strength and functional capacity, fatigue, and sensory disturbances due to the neurotoxic effects have been well known. Chemotherapy-induced peripheral neuropathy (CIPN) is a condition that is characterized by main loss of cutaneous sensation especially in the distal part of the extremities. CIPN affects approximately 30-40% of patients with cancer undergoing chemotherapy. Loss of sensation in distal sides of upper and lower extremities may cause not only deterioration of fine hand skills but also loss of balance and thereby one's mobility and independence are detrimentally affected. Thus, this study is aimed to assess CIPN in patients with cancer undergoing chemotherapy in a longitudinal design by assessing the cutaneous function of the sensory nerves and related effect of motor function.

详细描述

Chemotherapy-induced peripheral neuropathy (CIPN) which affects over 30-40% of patients with cancer undergoing chemotherapy cause cutaneous loss of sensation. A specific and selective function carries great importance not only in daily life but also in task-specific complex movements. Since the long-term survival of cancer is increased, back to work is quite important in both one's participation in community life and financial issues. Irrespective of age or other socio-clinical and socio-demographic characteristics, patients may be affected detrimentally after systemic adjuvant chemotherapy implementation in the perspective of sensory and motor aspects. Thus, this study is aimed to assess cutaneous sensory and motor function in patients with cancer undergoing chemotherapy in a longitudinal design.

Study Setting:

This research was planned as an observational-cross sectional cohort study within a longitudinal design. Patients diagnosed with cancer and applied to medical oncology unit in Izmir Bakircay University Çiğli State and Training Hospital for systemic adjuvant chemotherapy will be assessed in three different time points set as following: Time 1: before chemotherapy application, Time 2: interim time point (approx.8 weeks later) and Time 3: post-chemotherapy time point (12-20 weeks later after initial assessment). The main outcome measures were set as handgrip strength and Minnesota Rate of Manipulation Test (MRMT) for motor function while Semmens-Weinstein Monofilament Test (SWMT) for sensory evaluation. Secondarily, patients' quality of life and fatigue will be assessed with European Organization of Research and Treatment of Cancer (EORTC) specific scales such as QLQ-C30 for general quality of life and QLQ-FA12 for fatigue.

Hand Grip Strength:

Hand-Grip Strength Handgrip strength will be assessed with Lafayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being a Volunteer to participate this study
  • Having diagnosed with Cancer
  • Having available to be implemented to adjuvant systemic chemotherapy application

排除标准

  • Prior diagnosed with diabetic polyneuropathy
  • Neo-adjuvant chemotherapy
  • Having scar tissue in the palmar and/or plantar side(s) of the skin might affect the sensory evaluation
  • Having Multiple Sclerosis or other neurological diseases which might affect neural conductivity disturbances and/or sensory loss

结局指标

主要结局

Hand Grip Strength

时间窗: 6 weeks

Motor Function Asssesment via Hand-Grip Strength

Minnesota Rate of Manipulation Test

时间窗: 6 weeks

Functional Assessment of Hands

Semmens Weinstein Monofilament Test (SWMT)

时间窗: 6 weeks

Evaluation of Cutaneous Sensory Function

次要结局

  • The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)(6 weeks)
  • Functional Assessment of Cancer Therapy-Breast (FACT-B+)(6 weeks)

研究者

发起方
Izmir Bakircay University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alper Tuğral

PT, MSc

Izmir Bakircay University

研究点 (1)

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