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NCT03254394 · ClinicalTrials.gov registry record · Phase 1
Lidocaine for Oxaliplatin-induced Neuropathy
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03254394: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT03254394 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03254394, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Oxaliplatin-induced neuropathy is a major dose-limiting side effect in patients with colorectal cancer treated with the FOLFOX chemotherapy regimen. Hypersensitivity to cold is the sensory hallmark of oxaliplatin-induced neuropathy, and it can predict the development of long-term neuropathy. In this study, the investigators aim to determine whether intravenous lidocaine can prevent oxaliplatin-induced cold hypersensitivity.
Primary Outcome
The intensity of cold pain and cold unpleasantness is evaluated separately, assessed daily on a 0-10 scale, upon holding a pre-cooled (\~8°C) metal cylinder for 10 seconds. the area under the curve of cold pain and cold unpleasantness vs time is calculated per chemotherapy cycle (every two weeks) and serves as a primary outcome measure. For intervention (lidocaine+FOLFOX) and control (placebo+FOLFOX) groups, the average of cold pain AUC and cold unpleasantness AUC over 7 cycles was calculated.
Interventions
- DRUG Placebo
- DRUG FOLFOX regimen
- DRUG Lidocaine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 1 |
What the finished NCT03254394 record still lists
NCT03254394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03254394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03254394 about?
NCT03254394 is a clinical study titled "Lidocaine for Oxaliplatin-induced Neuropathy". Oxaliplatin-induced neuropathy is a major dose-limiting side effect in patients with colorectal cancer treated with the FOLFOX chemotherapy regimen. Hypersensitivity to cold is the sensory hallmark of oxaliplatin-induced neuropathy, and it can predict the development of long-term neuropathy. In this...
What is the current status of trial NCT03254394?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-09-15. Estimated completion is 2021-04-01.
What interventions are being tested in trial NCT03254394?
The interventions under investigation include: Placebo (DRUG), FOLFOX regimen (DRUG), Lidocaine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03254394?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03254394's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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