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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

Study 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
13,657 Previous Clinical Trials
40,933,662 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,578 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still admitting participants for this clinical experiment?

"Confirmed. According to clinicaltrials.gov, this experiment commenced recruiting on the 18th of November 2019 and updated most recently on May 12th 2022. At present, it is enrolling a total of 18 patients from one location only."

Answered by AI

How many individuals have consented to participate in this trial?

"Aye, the information accessible on clinicaltrials.gov reveals that this investigation is still recruiting participants. It was originally posted on November 18th 2019 and most recently revised May 12th 2022; seeking to enrol a total of eighteen patients at one medical centre."

Answered by AI

Has Alpha Lipoic Acid been validated by the Food and Drug Administration?

"Our team concluded that Alpha Lipoic Acid is relatively untested, receiving a score of 1 out of 3. This reflects the fact that this Phase 1 trial has not yet generated enough data to substantiate its safety or efficacy."

Answered by AI

Are there any specific criteria for participation in this experiment?

"In order to qualify for this clinical trial, patients must have a diagnosis of oral squamous cell carcinoma and be aged between 18-100 years old. The research team is currently in search of 18 volunteers."

Answered by AI

Could you provide information on any other investigations concerning Alpha Lipoic Acid?

"Currently, 8 trials assessing the efficacy of Alpha Lipoic Acid are underway. One trial has progressed to Phase 3 status while all other studies remain in earlier phases. Furthermore, these investigations are happening across 18 different locations with a major concentration located in Aurora, Colorado."

Answered by AI

What health issues can Alpha Lipoic Acid help to alleviate?

"Alpha Lipoic Acid is an effective way to address diabetic neuralgia, improve dietary and nutritional therapies, and supplement nutrition."

Answered by AI

Does the current protocol of this medical trial encompass patients aged eighty-five and older?

"This research is seeking participants who are of legal age and have yet to reach their centennial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC
2020. "Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04042935.
~1 spots leftby Apr 2025
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