- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05866653
Effect of Lidocaine Transdermal Patch as Add-On Therapy in Treatment of Oxaliplatin Induced Peripheral Neuropathy in Colorectal Cancer Patients
May 22, 2023 updated by: Sharmeen Tania Shovah, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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.
But it has dose related side effects and intolerability Clinical data shows that administration of pregabalin tablet 150mg/day for 2-6 weeks significantly improves the neuropathy induced by oxaliplatin in 48% of the patients.
Lidocaine transdermal patch (L5%P) is a local anesthetic medication with analgesic effect.
It works in a different mechanism from pregabalin by stopping nerves from sending pain signal by blocking sodium ion channel, thus reduces ectopic nerve discharges, relieves hyperalgesia and modulates the inflammatory response.
It is applied on most painful area on skin and shows further benefits as low systemic absorption (3-5%), reduced risk of systemic toxicity, minimized side effects and reduced potential of drug interactions.
Clinical data have indicated its efficacy in neuropathic pain conditions (PHN), including diabetic polyneuropathy (DPN) and herpes zoster neuralgia.
Moreover, Lidocaine inhibits proliferation and induces apoptosis in colorectal cancer cells by up regulating mir-520a-3p and targeting EGFR.
No study has been conducted yet to determine the effect of lidocaine patch on OIPN but theoretically it might be a potentially useful treatment option.
This proposed study is therefore an effort whether there is any role of lidocaine patch in symptomatic improvements of OIPN as add on therapy with pregabalin tablet.
This study will be a randomized, double-blind, placebo controlled clinical trial.
It will be conducted in the department of pharmacology, BSMMU in collaboration with National institute of cancer research and hospital (NICRH) from the day of approval by the IRB to July, 2023.
A total of ninety (90) patients from indoor department of clinical oncology will be selected for the study according to inclusion and exclusion criteria.
After receiving oxaliplatin treatment regimen and after development of OIPN with pain intensity ≥ 4 in VAS scores at baseline, participants will randomly be assigned into two intervention groups.
Group A (45) will receive lidocaine transdermal patch (1 patch/day for 12 hours) along with pregabalin tablet (75mg/day) for 10 days and group B (45) will receive placebo patch (1patch/day for12 hours) along with pregabalin tablet (75mg/day) for 10 days.
Every cycle interval consists 3 weeks and assessment of OIPN will be done at baseline and after 3rd and 6th weeks.
Quality of life will be measured by FACT/GOG-NTX neurotoxicity scoring and severity of neuropathy by NCI-CTCAE grading scale.
Comparison between the effects of interventions in two groups can be made by using data collected from each group
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sharmeen Tania Shovah, MBBS,MD
- Phone Number: 01711155512
- Email: dr.taniapharma@gmail.com
Study Contact Backup
- Name: Prof.Md.Sayedur Rahman, M.Phil,FCPS
- Phone Number: 01971840757
Study Locations
-
-
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Dhaka, Bangladesh, 1000
- Recruiting
- Bangabandhu Sheikh Mujib Medical University
-
Contact:
- Registrar
- Phone Number: 889661064
- Email: registrar@bsmmu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Arm
This group will consist of 45 patients who are scheduled to receive oxaliplatin based chemotherapy regimen.
After receiving 2 cycles of chemotherapy usually patient develops OIPN.
Patients who will develop OIPN with pain intensity ≥4 in VAS scores will be included.
The patients will be treated with one lidocaine transdermal patch/day for 12 hours for 10 days as add on therapy with standard treatment by oncologist.
|
The topical pain-relieving treatment 5% lidocaine transdermal patch has been registered in the USA since 1999
|
Placebo Comparator: Placebo Arm
This group will consist of 45 patients who are scheduled to receive oxaliplatin based chemotherapy regimen.
After receiving 2 cycles of chemotherapy usually patient develops OIPN.
Patients who will develop OIPN with pain intensity ≥4 in VAS score will be included.
The patients will be treated with one placebo patch/day for 12 hours for 10 days as add on therapy with standard treatment by oncologist.
|
The topical pain-relieving treatment 5% lidocaine transdermal patch has been registered in the USA since 1999
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from Visual Analogue Scale (VAS) pain score
Time Frame: From the baseline assessment to 3 and 6 weeks
|
Measure pain
|
From the baseline assessment to 3 and 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2023
Primary Completion (Anticipated)
July 30, 2023
Study Completion (Anticipated)
July 30, 2023
Study Registration Dates
First Submitted
May 10, 2023
First Submitted That Met QC Criteria
May 10, 2023
First Posted (Actual)
May 19, 2023
Study Record Updates
Last Update Posted (Actual)
May 23, 2023
Last Update Submitted That Met QC Criteria
May 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- BSMMU/20023/265
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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