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Trial Title:
Rood's Approach and Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
NCT ID:
NCT05882396
Condition:
Colorectal Cancer
Peripheral Neuropathy
Conditions: Official terms:
Colorectal Neoplasms
Peripheral Nervous System Diseases
Conditions: Keywords:
Rood's approach
Oxaliplatin-induced peripheral neuropathy
Colorectal cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Sixty Patients with colorectal cancer have oxaliplatin-induced peripheral neuropathy.
will be indiscriminately assigned to two groups.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Rood's approach
Description:
Patients will receive Rood's approach includes various facilitatory and inhibitory
techniques.
Arm group label:
Rood's approach group
Intervention type:
Other
Intervention name:
Traditional physical therapy program
Description:
Participants will be engaged in aerobic exercises and balance training, three times per
week for twelve weeks.
Arm group label:
Rood's approach group
Arm group label:
Traditional physical therapy program group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Start date:
June 1, 2023
Completion date:
January 11, 2024
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05882396
