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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Prof.Md.Sayedur Rahman, M.Phil,FCPS
  • Phone Number: 01971840757

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Recruiting
        • Bangabandhu Sheikh Mujib Medical University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: lidocaine transdermal patch
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.
Drug: lidocaine transdermal patch
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings