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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

No Placebo-Only Group

Summary

This trial is testing alpha lipoic acid, an antioxidant supplement, in patients with head and neck cancer who are receiving treatment. The goal is to find the safest dose that helps protect cells and reduce inflammation. This could make the cancer treatment more effective and less harmful.

Eligible Conditions

Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, 3 and 6 month follow up visits

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTD and RP2D of ALA during chemoradiotherapy for HNSCC patients

Secondary study objectives

Change in Oral Mucositis Assessment Scale (OMAS) from baseline

Change in Visual Assessment Score (VAS) for pain from baseline

Head

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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