Rood's Approach and Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients (NCT05882396) | Clinical Trial Compass
UnknownNot Applicable
Rood's Approach and Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
60 participantsStarted 2023-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NCT-CTCAE peripheral neuropathy grading
Timeframe: Change from baseline at twelve weeks after the intervention
2
The Ntx-12 questionnaire
Timeframe: Change from baseline at twelve weeks after the intervention
3
Brief Pain Inventory Short Form (BPI-SF) Bworst pain
Timeframe: Change from baseline at twelve weeks after the intervention
4
Total Neuropathy Score
Timeframe: Change from baseline at twelve weeks after the intervention