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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Cancer; Peripheral Neuropathy
• Interventions: Other: Rood's approach; Other: Traditional physical therapy program

• Registration Number: NCT05882396
• Lead Sponsor: Cairo University

Brief Summary

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

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

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-26
• Last Update Submitted: 2023-05-26
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31
• Study Start: 2023-06-01
• Primary Completion: 2023-12-28
• Study Completion: 2024-01-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rood's approach group	Rood's approach	Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.
Traditional physical therapy program group	Traditional physical therapy program	Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.
Rood's approach group	Traditional physical therapy program	Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.

Primary Outcome Measures

Name	Time	Method
The Ntx-12 questionnaire	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
The 4-Stage Balance Test	Change from baseline at twelve weeks after the intervention	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