Clinical trial NCT05882396: Rood's Approach and Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
Official title: Efficacy of Rood's Approach on Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Peripheral Neuropathy
Keywords: Rood's approach
Oxaliplatin-induced peripheral neuropathy
Colorectal cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty Patients with colorectal cancer have oxaliplatin-induced peripheral neuropathy. will be indiscriminately assigned to two groups.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: NCT-CTCAE peripheral neuropathy grading
timeFrame: Change from baseline at twelve weeks after the intervention
measure: The Ntx-12 questionnaire
timeFrame: Change from baseline at twelve weeks after the intervention
measure: Brief Pain Inventory Short Form (BPI-SF) Bworst pain
timeFrame: Change from baseline at twelve weeks after the intervention
measure: Total Neuropathy Score
timeFrame: Change from baseline at twelve weeks after the intervention
Secondary outcomes:
measure: The 4-Stage Balance Test
timeFrame: Change from baseline at twelve weeks after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer at Faculty of Physical Therapy, Cairo University
name: Shaimaa MA El Sayeh, PhD
role: PRINCIPAL_INVESTIGATOR
References: