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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 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
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 moreTrial 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
13,842 Previous Clinical Trials
41,002,995 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,603 Total Patients Enrolled
Cancer League of ColoradoOTHER
10 Previous Clinical Trials
367 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking gabapentin, pregabalin, amitriptyline, nortriptyline, or duloxetine.You are allergic or have a sensitivity to alpha lipoic acid.You are not suitable for radiation treatment with a total planned dose higher than 30 Gy for long-term or supportive care purposes.
Research Study Groups:
This trial has the following groups:- Group 1: Alpha Lipoic Acid (ALA) during chemoradiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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