Completed
PHASE1
INTERVENTIONAL
NCT04042935
Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Detailed Description
The study will be completed when the MTD and RP2D are determined. This will be either when 2 or more patients have a DLT at a particular dose level, or when 6 patients have completed treatment at the highest dose level (600 mg TID). The final 3 patients enrolled at the highest tolerated dose will also complete PK studies.
Interventions
Name:
Alpha Lipoic Acid
Type:
DRUG
Description:
Stage II-IVB HNSCC patients receiving concurrent systemic therapy and radiation in the definitive, adjuvant, or palliative setting will receive ALA according to their prescribed dose level. ALA will be taken orally or per feeding tube. It will start 1 week prior to the start of CRT, continue on through CRT, and then continue for 2 weeks after the completion of CRT. Patients will be given dosing diaries to document date and time of each drug administration as well as any missed doses. They will also have weekly visits to report AEs and concurrent medications, have a history and physical exam, report VAS pain scores and OMAS scores, and fill FACT-HN surveys.
Primary Outcomes
Measure:
MTD and RP2D of ALA during chemoradiotherapy for HNSCC patients
TimeFrame:
18 months
Description:
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.
Trial Information
NCT ID
NCT04042935
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
University of Colorado, Denver
Last Updated
December 15, 2025