Efficacy of Rood's Approach on Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- The Ntx-12 questionnaire
研究概览
简要总结
Oxaliplatin-induced chronic peripheral neuropathy is of major concern to oncologists and patients as it has been shown to affect patients' health-related quality of life. Although a number of interventions have been implicated, none of them can be recommended for clinical use. This therapeutic failure reflects a poor understanding of the real mechanism of oxaliplatin-induced neuropathy. However, oxidative stress is identified to be one of the main biomolecular dysfunctions in this neuropathy. Rood's approach is a neurophysiological approach that is based on reflexes of the central nervous system in which the sensory stimulation provides desired muscular response and was specially designed for patients with motor control problems. It was developed by Margeret Rood in 1940. According to Rood, sensory stimulation can activate or deactivate the receptor by facilitation or inhibition, which makes it possible to get the desired muscular response.
详细描述
So, the purpose of the study is to investigate the efficiency of Rood's approach on oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient can participate in the study if they had at least one cycle of oxaliplatin chemotherapy.
- •Colorectal cancer patients who have oxaliplatin-induced peripheral neuropathy, the patients included in the study with mild to moderate neuropathy according to mTNS.
- •Patients from both genders.
- •Their ages range from 18 to 60 years old.
排除标准
- •Patients who had a history of any other neuropathy as diabetic neuropathy.
- •Patients with an unstable medical condition during chemotherapy.
- •Patients who are starting new therapy or dose modification during the study period.
- •Patients with morbid obesity "body mass index >40%".
- •Patients with a history of non-surgically repaired nerve compression injuries such as carpal tunnel, brachial plexopathy, spinal stenosis, and spinal nerve root compression.
- •Patients with a history of central nervous system primary or metastatic malignancy.
结局指标
主要结局
The Ntx-12 questionnaire
时间窗: Change from baseline at twelve weeks after the intervention
It is comprised of 12 statements intended to measure the severity and impact of peripheral sensory neuropathy on patients' lives. Patients were instructed to complete the Arabic version of the Ntx-12 and choose the number corresponding to how true each statement was for them using a Likert-type scale, with 0 indicating not at all; 1, a little bit; 2, somewhat; 3, quite a bit; and 4, very much.
Brief Pain Inventory Short Form (BPI-SF) Bworst pain
时间窗: Change from baseline at twelve weeks after the intervention
The BPI-SF assesses pain at its worst, least, average, and now (current pain). Patients respond on 0-to-10 numerical rating scales. Each scale presented as a row of equidistant numbers, where 0 = no pain\^ and 10 = pain as bad as you can imagine.
NCT-CTCAE peripheral neuropathy grading
时间窗: Change from baseline at twelve weeks after the intervention
It consists of of 5 grades; Grade (1) is asymptomatic may be accompanied by loss of tendon reflex or paraesthesia. Grade (2) is moderate symptoms which limit instrumental activities of daily life Grade (3) is severe symptoms which limit self-care activates of daily life. Grade (4) is life threatening consequences or urgent intervention indicated. Grade (5) is death.
Total Neuropathy Score
时间窗: Change from baseline at twelve weeks after the intervention
used to measure these constructs. It includes 6 items graded from 0 to 4 according to the patients' symptoms, the total grade from 0 to 24. The higher grade the worse neuropathy. It graded as mild (1:9), moderate (10:19) and (20:24) severe.
次要结局
- The 4-Stage Balance Test(Change from baseline at twelve weeks after the intervention)
研究者
Shaimaa Mohamed Ahmed Elsayeh
Lecturer of physical therapy
Cairo University