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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Peripheral Neuropathy
• Intervention / Treatment: Other: Rood's approach; Other: Traditional physical therapy program

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaimaa MA El Sayeh, PhD; Phone Number: +201007766160; Email: sh.sayeh87@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Shaimaa MA El Sayeh, PhD, Lecturer at Faculty of Physical Therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): December 28, 2023
• Study Completion (Estimated): January 11, 2024

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal cancer; Oxaliplatin-induced peripheral neuropathy; Rood's approach
• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neuromuscular Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Peripheral Nervous System Diseases
• Other Study ID Numbers: P.T.REC/012/004322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No