Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05488873

A Study of Topical Pirenzepine or Placebo in Oncology Patients With Chemotherapy Induced Peripheral Neuropathy

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Study of Topical Pirenzepine or Placebo for the Prevention of Dose Limiting Chemotherapy Induced Peripheral Neuropathy in Oncology Patients Administered Carboplatin and Paclitaxel

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled adaptive study of the safety, tolerability, and exploratory efficacy of once-daily topical WST-057 administered for up to 19 weeks (or up to 24 weeks for subjects who experience a chemotherapy dose delay) to subjects who are also receiving 6 cycles (3 weeks apart) of Carboplatin AUC 5-6 and Paclitaxel 175 mg/m2 (with dose adjustment per institutional guidelines permitted).

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled adaptive study of the safety, tolerability, and exploratory efficacy of once-daily topical WST-057 administered for up to 19 weeks (or up to 24 weeks for subjects who experience a chemotherapy dose delay) to subjects who are also receiving 6 cycles (3 weeks apart) of Carboplatin AUC 5-6 and Paclitaxel 175 mg/m2 (with dose adjustment per institutional guidelines permitted). A Data Safety Monitoring Committee will review the safety data for all patients upon the completion of the first 10 patients. An interim analysis for safety and futility (primary and secondary endpoints) will be conducted after the first 20 subjects complete the trial. Based on this analysis an additional 20 subjects will be randomized and the power assessed. Depending on the statistical power after 40 subjects complete, a determination will be made as to whether or not to continue the recruitment up to a maximum of 60 subjects' completing the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05488873
Study type Interventional
Source WinSanTor, Inc
Contact Angela Hansen
Phone 858-848-4831
Email ahansen@winsantor.com
Status Recruiting
Phase Phase 2
Start date November 22, 2022
Completion date May 30, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05528263 - Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial) N/A
Completed NCT03272919 - Chemotherapy Induced Peripheral Neuropathy (CIPN) N/A
Not yet recruiting NCT06430814 - Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
Not yet recruiting NCT05840562 - Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy Phase 3
Completed NCT02553863 - The Effectiveness and Cost-effectiveness of Acupuncture in Managing Chemotherapy-induced Peripheral Neuropathy N/A
Recruiting NCT04786977 - Physiologic Measure of VIPN
Completed NCT03655587 - Impact of an Orthotic Intervention in Children With Peripheral Neuropathy N/A
Completed NCT03687970 - A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN) N/A
Terminated NCT04770402 - Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients N/A
Completed NCT03254394 - Lidocaine for Oxaliplatin-induced Neuropathy Phase 1/Phase 2
Completed NCT04367480 - Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy N/A
Recruiting NCT04237194 - A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
Completed NCT04843410 - Effect of Exercise in the Management of Peripheral Neuropathy N/A
Terminated NCT03782402 - Cannabinoids for Taxane Induced Peripheral Neuropathy Phase 2
Not yet recruiting NCT06389721 - Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
Recruiting NCT05121558 - The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy) Phase 3
Withdrawn NCT04492436 - A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo Phase 2
Not yet recruiting NCT03112057 - Visualize Nociceptor Changes in Neuropathic Human N/A
Completed NCT04262778 - Diagnostic of Chemotherapy Induced Neuropathy in Children
Recruiting NCT06324344 - Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN) N/A