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Alpha Lipoic Acid for Head and Neck Squamous Cell Carcinoma

Phase 1
Waitlist Available
Led By Jessica McDermott
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, 3 and 6 month follow up visits
Awards & highlights

Summary

This trial is testing a new cancer treatment that combines alpha lipoic acid with chemotherapy and radiation.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, 3 and 6 month follow up visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, 3 and 6 month follow up visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD and RP2D of ALA during chemoradiotherapy for HNSCC patients
Secondary outcome measures
Change in Oral Mucositis Assessment Scale (OMAS) from baseline
Change in Visual Assessment Score (VAS) for pain from baseline
Head
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Alpha Lipoic Acid (ALA) during chemoradiationExperimental Treatment1 Intervention
Stage II-IVB HNSCC patients receiving concurrent systemic therapy and radiation as standard of care will receive ALA before, during, and after treatment. The drug will have dose escalation in a 3+3 design. The first group of 3 patients will receive 600 mg twice a day. If there are no DLTs, the next 3 patients will receive the highest dose of 600 mg three times a day. If one or more patients develop a DLT at any of the dosing levels, the group will either be expanded or dropped to a lower dose level.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpha Lipoic Acid
2018
Completed Phase 3
~310

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,396 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,758 Previous Clinical Trials
2,166,255 Total Patients Enrolled
Cancer League of ColoradoOTHER
8 Previous Clinical Trials
226 Total Patients Enrolled

Media Library

Alpha Lipoic Acid Clinical Trial Eligibility Overview. Trial Name: NCT04042935 — Phase 1
Head and Neck Squamous Cell Carcinoma Research Study Groups: Alpha Lipoic Acid (ALA) during chemoradiation
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Alpha Lipoic Acid Highlights & Side Effects. Trial Name: NCT04042935 — Phase 1
Alpha Lipoic Acid 2023 Treatment Timeline for Medical Study. Trial Name: NCT04042935 — Phase 1
~1 spots leftby Jul 2025