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

NCT05866653 | Unknown Phase 2 FDA Drug

• 1 other identifier: BSMMU/20023/265
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Changes from Visual Analogue Scale (VAS) pain score

  Measure pain

  From the baseline assessment to 3 and 6 weeks

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

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

Placebo Arm

PLACEBO COMPARATOR

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

Interventions

lidocaine transdermal patch DRUG

The topical pain-relieving treatment 5% lidocaine transdermal patch has been registered in the USA since 1999

Control Arm; Placebo Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

RECRUITING

Central Study Contacts

Sharmeen Tania Shovah, MBBS,MD

CONTACT

01711155512; dr.taniapharma@gmail.com

Prof.Md.Sayedur Rahman, M.Phil,FCPS

CONTACT

01971840757

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: March 25, 2023
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE

Locations

BA (1)