Effect of Lidocaine Transdermal Patch as Add-On Therapy in Treatment of Oxaliplatin Induced Perip… (NCT05866653) | Clinical Trial Compass
UnknownPhase 2
Effect of Lidocaine Transdermal Patch as Add-On Therapy in Treatment of Oxaliplatin Induced Peripheral Neuropathy in Colorectal Cancer Patients
Bangladesh90 participantsStarted 2023-03-25
Plain-language summary
Oxaliplatin (OXA) is a third-generation platinum-based chemotherapeutic drug with better efficacy for colorectal carcinoma (CRC). Oxaliplatin-induced peripheral neuropathy (OIPN) is one of the most frequent dose-limiting or even treatment-terminating side effects that impair optimal treatment regimens in a significant proportion of patients from 19% to over 85%. Thus, OIPN impacts the quality of life and the patient's survival. OIPN is a clinical challenge and healthcare professionals are facing this challenge with a limited selection of analgesics and nonpharmacological therapies. Pregabalin is a structural derivative of GABA and is one of the effective treatment modalities for OIPN. It binds with high affinity to the alpha2-delta site of voltage-gated calcium channels in central nervous system tissues and inhibits neurotransmitter release, thus producing anti-nociceptive and anti-seizure effects.
Who can participate
Age range
18 Years – 70 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:
* Adults with stage II, III and IV colorectal cancers, scheduled to receive an oxaliplatin-based chemotherapy regimen.
* Patients could be receiving concomitant chemotherapy.
* Patient ECOG performance status 0-3.
Exclusion Criteria:
* • Pre-existing symmetric peripheral painful neuropathy due to diabetes mellitus or other causes.
* Presence of brain metastases.
* Renal insufficiency (calculated creatinine clearance\<30ml/min).
* Moderate to severe hepatic insufficiency (ALTor AST \>3times upper level of normal if no liver metastases are present; ALTor AST \>5 times upper limit of normal if liver metastases are present).
* Current uncontrolled cardiac arrhythmias (non-sinus rhythm).
* Any topical treatment with other medication for neuropathic pain.
* Pregnancy or breast feeding.
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
Changes from Visual Analogue Scale (VAS) pain score
Timeframe: From the baseline assessment to 3 and 6 weeks
Trial details
NCT IDNCT05866653
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh