Effects of Oxaliplatin-Induced Peripheral Neuropathy on Hand Function, Grip Strength and Quality of Life in Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Hand Grip Strength Assessment
研究概览
简要总结
The aim of this study is to investigate the effects of oxaliplatin-induced peripheral neuropathy on hand function, grip strength, and quality of life in colorectal cancer patients. Assessing the motor symptoms of CIPN and sharing the results in clinical settings will help guide evidence-based practices and interventions.
详细描述
Oxaliplatin is a chemotherapy drug frequently used in the treatment of colorectal cancers, the third most common type of cancer. However, oxaliplatin is associated with long-term neurotoxicity, the most common dose-limiting side effect. Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of platinum-based chemotherapy agents, such as oxaliplatin. CIPN limits patients' ability to tolerate treatment and adversely affects long-term quality of life and physical functionality. In individuals undergoing colorectal cancer treatment, the prevalence of CIPN has been reported as 58% at 6 months, 45% at 12 months, 32% at 24 months, and 24% at 36 months post-treatment. Additionally, oxaliplatin exhibits a "coasting phenomenon," in which CIPN symptoms continue to worsen for approximately 3 months after treatment. Although the incidence and sensory symptoms of oxaliplatin-induced CIPN during chemotherapy have been well documented, the chronic-phase motor symptom burden of oxaliplatin-induced CIPN has not been reported. Studies investigating the motor aspects of CIPN are insufficient, and further research is needed to determine its prevalence, progression, and impact on functional outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving chemotherapy due to a diagnosis of locally advanced or metastatic colorectal cancer,
- •Having received at least 3 cycles of single or combined oxaliplatin-based chemotherapy,
- •Aged 20 years or older,
- •No speech or hearing impairments,
- •Voluntary participation in the study.
排除标准
- •Development of peripheral neuropathy due to causes other than chemotherapy (e.g., tumor compression, nutritional disorders, infections, or major systemic diseases such as diabetes mellitus),
- •Presence of mental or cooperation problems.
结局指标
主要结局
Hand Grip Strength Assessment
时间窗: baseline only
Participants' hand grip strength will be evaluated using the Saehan Hydraulic Hand Dynamometer (SAEHAN Corporation, Yangdeok-Dong, Masan, South Korea) to assess the functional status of the upper extremity and clinical outcomes.
Hand Function Assessment (Duruöz Hand Index)
时间窗: baseline
Hand function related to daily activities will be assessed using the Duruöz Hand Index questionnaire. This questionnaire consists of 18 items covering five domains: kitchen tasks, dressing, personal hygiene, work activities, and other activities. Each item is scored on a scale from 0 to 5.
Hand Function Assessment (Michigan Hand Outcomes Questionnaire)
时间窗: baseline
Overall hand function, including parameters such as pain, aesthetic perception, and patient satisfaction, will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ). The MHQ was developed in 1998 by hand surgeon Chung and colleagues Pillsbury, Walters, Hayward, and Arbor. The questionnaire consists of six domains: overall hand function, activities of daily living, work performance, pain, aesthetics, and patient-reported hand function. Scores range from 0 to 100. Responses are rated on a scale of 1 to 5 and then normalized to obtain scores for each subdomain.
Fine Motor Skill Assessment (Minnesota Manual Dexterity Test)
时间窗: baseline
Fine motor skills will be assessed using the Minnesota Manual Dexterity Test (MMDT), which evaluates unilateral and bilateral manual performance of the upper extremities through placement and turning tasks. In the placement test, participants are required to place 60 cylinders one by one into holes on a board as quickly as possible using one hand. The dominant and non-dominant hands are evaluated separately. In the turning test, at the start of the test, all 60 cylinders are placed in the holes. Participants are asked to pick up each cylinder with one hand, rotate it, and return it to the hole using the other hand, repeating this process for all 60 cylinders individually.
Nine-Hole Peg Test (NHPT)
时间窗: Baseline
The Nine-Hole Peg Test is a standardized, well-established, and reliable tool for assessing hand function.
Hand Grip Strength Assessment
时间窗: baseline only
Participants' hand grip strength will be evaluated using the Saehan Hydraulic Hand Dynamometer (SAEHAN Corporation, Yangdeok-Dong, Masan, South Korea) to assess the functional status of the upper extremity and clinical outcomes.
Finger Grip Strengths (Tip, Key, and Palmar Grip)
时间窗: baseline only
A hydraulic pinch gauge will be used to measure finger grip strengths.
Hand Function Assessment (Duruöz Hand Index)
时间窗: baseline
Hand function related to daily activities will be assessed using the Duruöz Hand Index questionnaire. This questionnaire consists of 18 items covering five domains: kitchen tasks, dressing, personal hygiene, work activities, and other activities. Each item is scored on a scale from 0 to 5.
Hand Function Assessment (Michigan Hand Outcomes Questionnaire)
时间窗: baseline
Overall hand function, including parameters such as pain, aesthetic perception, and patient satisfaction, will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ). The MHQ was developed in 1998 by hand surgeon Chung and colleagues Pillsbury, Walters, Hayward, and Arbor. The questionnaire consists of six domains: overall hand function, activities of daily living, work performance, pain, aesthetics, and patient-reported hand function. Scores range from 0 to 100. Responses are rated on a scale of 1 to 5 and then normalized to obtain scores for each subdomain.
Fine Motor Skill Assessment (Minnesota Manual Dexterity Test)
时间窗: baseline
Fine motor skills will be assessed using the Minnesota Manual Dexterity Test (MMDT), which evaluates unilateral and bilateral manual performance of the upper extremities through placement and turning tasks. In the placement test, participants are required to place 60 cylinders one by one into holes on a board as quickly as possible using one hand. The dominant and non-dominant hands are evaluated separately. In the turning test, at the start of the test, all 60 cylinders are placed in the holes. Participants are asked to pick up each cylinder with one hand, rotate it, and return it to the hole using the other hand, repeating this process for all 60 cylinders individually.
Nine-Hole Peg Test (NHPT)
时间窗: Baseline
The Nine-Hole Peg Test is a standardized, well-established, and reliable tool for assessing hand function.
次要结局
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(baseline)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20)(baseline)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(baseline)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20)(baseline)
研究者
Ozge Koseoglu
research assisstant
Fenerbahce University