Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC

PHASE1CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

February 27, 2020

Primary Completion Date

February 19, 2021

Study Completion Date

September 24, 2021

Conditions
HNSCC
Interventions
DRUG

Alpha Lipoic Acid

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.

Trial Locations (1)

80045

University of Colorado Hospital, Aurora

All Listed Sponsors
collaborator

Cancer League of Colorado

OTHER

lead

University of Colorado, Denver

OTHER

NCT04042935 - Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC | Biotech Hunter | Biotech Hunter