Spots Global Cancer Trial Database for Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC
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Trial Identification
Brief Title: Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC
Official Title: Alpha Lipoic Acid to Decrease Treatment Related Pain and Side Effects During Concurrent Chemoradiation in HNSCC
Study ID: NCT04042935
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Hospital, Aurora, Colorado, United States
Contact Details
Name: Jessica McDermott
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR
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