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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Peripheral Neuropathy; Colorectal Cancer

Treatments: Other: Traditional physical therapy program; Other: Rood's approach

Study type: Interventional

Funder types: Other

Identifiers

NCT05882396

P.T.REC/012/004322

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Rood's approach group

Active Comparator group

Description:

Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.

Treatment:

Other: Traditional physical therapy program

Other: Rood's approach

Traditional physical therapy program group

Active Comparator group

Description:

Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.

Treatment:

Other: Traditional physical therapy program