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Effect of Lidocaine Transdermal Patch as Add-On Therapy in Treatment of Oxaliplatin Induced Peripheral Neuropathy in Colorectal Cancer Patients

Primary Purpose

Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients

Status
Recruiting
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
lidocaine transdermal patch
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bangabandhu Sheikh Mujib Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Control Arm

Placebo Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes from Visual Analogue Scale (VAS) pain score
Measure pain

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
May 22, 2023
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT05866653
Brief Title
Effect of Lidocaine Transdermal Patch as Add-On Therapy in Treatment of Oxaliplatin Induced Peripheral Neuropathy in Colorectal Cancer Patients
Official Title
Effect of Lidocaine Transdermal Patch as Add-On Therapy in Treatment of Oxaliplatin Induced Peripheral Neuropathy in Colorectal Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lidocaine transdermal patch
Intervention Description
The topical pain-relieving treatment 5% lidocaine transdermal patch has been registered in the USA since 1999
Primary Outcome Measure Information:
Title
Changes from Visual Analogue Scale (VAS) pain score
Description
Measure pain
Time Frame
From the baseline assessment to 3 and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharmeen Tania Shovah, MBBS,MD
Phone
01711155512
Email
dr.taniapharma@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Prof.Md.Sayedur Rahman, M.Phil,FCPS
Phone
01971840757
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Registrar
Phone
889661064
Email
registrar@bsmmu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effect of Lidocaine Transdermal Patch as Add-On Therapy in Treatment of Oxaliplatin Induced Peripheral Neuropathy in Colorectal Cancer Patients

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