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NCT04042935 · ClinicalTrials.gov registry record · Phase 1
Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC
A Phase 1 study of HNSCC, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT04042935: Completed Phase 1 study of HNSCC, sponsored by University of Colorado, Denver.
NCT04042935 is a Phase 1 study of HNSCC that has completed, run by University of Colorado, Denver. The registered enrollment target is 5 participants, below the 190-participant average among 23 other HNSCC trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04042935, a Phase 1 study of HNSCC, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I, single-center, non-randomized, 3+3 dose-escalation study of alpha lipoic acid given during chemotherapy-radiation in HNSCC patients with non-metastatic disease.
Primary Outcome
The maximum tolerated dose will be the highest dose in the planned schema that is given without evidence of SAEs. The RP2D will incorporate the MTD and PKs to determine the dose that is best tolerated as well as has the concentration necessary to be effective according to historical studies.
Conditions Studied
Interventions
- DRUG Alpha Lipoic Acid
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-02-27 |
| Est. Completion | 2021-09-24 |
| Phase | Phase 1 |
What the finished NCT04042935 record still lists
NCT04042935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 190-participant average among 23 other HNSCC trials with a reported enrollment target (97% lower).
The record links to 1 condition, with HNSCC appearing as the primary indexed condition, and to 1 intervention - of which Alpha Lipoic Acid is the first listed.
NCT04042935 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04042935 about?
NCT04042935 is a clinical study titled "Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC". This is a phase I, single-center, non-randomized, 3+3 dose-escalation study of alpha lipoic acid given during chemotherapy-radiation in HNSCC patients with non-metastatic disease.
What is the current status of trial NCT04042935?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-02-27. Estimated completion is 2021-09-24.
What conditions does trial NCT04042935 study?
This clinical trial studies the following conditions: HNSCC.
What interventions are being tested in trial NCT04042935?
The interventions under investigation include: Alpha Lipoic Acid (DRUG).
Who is sponsoring clinical trial NCT04042935?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04042935 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HNSCC
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04042935's enrollment target sits among peer trials
5 24th of 23 the lowest of 23 other HNSCC trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HNSCC 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.
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