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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05882396
• Other study ID #: P.T.REC/012/004322
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: January 11, 2024

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: Shaimaa MA El Sayeh, PhD
• Phone: +201007766160
• Email: sh.sayeh87[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 11, 2024
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Other:
• Rood's approach
Patients will receive Rood's approach includes various facilitatory and inhibitory techniques.
• Traditional physical therapy program
Participants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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