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

NCT ID: NCT05882396

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-01-11

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.

Conditions

Colorectal Cancer; Peripheral Neuropathy

Keywords

Rood's approach; Oxaliplatin-induced peripheral neuropathy; Colorectal cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rood's approach group

Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.

Group Type: ACTIVE_COMPARATOR

Rood's approach

Intervention Type: OTHER

Patients will receive Rood's approach includes various facilitatory and inhibitory techniques.

Traditional physical therapy program

Intervention Type: OTHER

Participants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks.

Traditional physical therapy program group

Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.

Group Type: ACTIVE_COMPARATOR

Traditional physical therapy program

Intervention Type: OTHER

Participants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks.

Interventions

Rood's approach

Patients will receive Rood's approach includes various facilitatory and inhibitory techniques.

Intervention Type: OTHER

Traditional physical therapy program

Participants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mohamed Ahmed Elsayeh

Lecturer of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaimaa MA El Sayeh, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer at Faculty of Physical Therapy, Cairo University

Central Contacts

Shaimaa MA El Sayeh, PhD

Role: CONTACT

Phone: +201007766160

Email: sh.sayeh87@gmail.com

Other Identifiers

P.T.REC/012/004322

Identifier Type: -

Identifier Source: org_study_id