Rood's Approach and Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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So, the purpose of the study is to investigate the efficiency of Rood's approach on oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.

Official Title
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Efficacy of Rood's Approach on Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients

Conditions
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Colorectal Cancer, Peripheral Neuropathy

Intervention / Treatment
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* Other: Rood's approach
* Other: Traditional physical therapy program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sixty Patients with colorectal cancer have oxaliplatin-induced peripheral neuropathy. will be indiscriminately assigned to two groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rood's approach group<br>Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy. | Other: Rood's approach<br>* Patients will receive Rood's approach includes various facilitatory and inhibitory techniques.<br>Other: Traditional physical therapy program<br>* Participants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks.<br>|
| Active Comparator: Traditional physical therapy program group<br>Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy. | Other: Traditional physical therapy program<br>* Participants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NCT-CTCAE peripheral neuropathy grading | 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. | Change from baseline at twelve weeks after the intervention | 
| The Ntx-12 questionnaire | 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. | Change from baseline at twelve weeks after the intervention | 
| Brief Pain Inventory Short Form (BPI-SF) Bworst pain | 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. | Change from baseline at twelve weeks after the intervention | 
| Total Neuropathy Score | 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. | Change from baseline at twelve weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 4-Stage Balance Test | is a recommended measure from the Centers for Disease Control and Prevention STEADI (Stopping Elderly Accidents, Deaths, and Injuries) falls campaign to recognize fall risk. An adult who cannot hold tandem stance for 10 seconds is at a higher risk for falls. [18] Patient A was able to stand in tandem stance for 2 seconds on each side. Patient B was able to stand on single leg stance for 10 seconds on each side | Change from baseline at twelve weeks after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rood's approach, Oxaliplatin-induced peripheral neuropathy, Colorectal cancer