Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC

Recruiting at 1 trial location

Overseen By Jessica Mcdermott, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Colorado, Denver

Must be taking: Cisplatin, Carboplatin, Cetuximab

Must not be taking: Gabapentin, Pregabalin, Amitriptyline, others

Disqualifiers: Pregnancy, Allergy to alpha lipoic acid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

5 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking gabapentin, pregabalin, amitriptyline, nortriptyline, or duloxetine if you are currently using them.

What data supports the effectiveness of the drug Alpha Lipoic Acid?

Research shows that Alpha Lipoic Acid can help improve symptoms in people with diabetic nerve pain and may have protective effects in conditions like spinal cord injury and endotoxic shock. It has also been studied for its potential benefits in cancer treatment and metabolic disorders. ^{1 2 3 4 5}

Is Alpha Lipoic Acid safe for humans?

Alpha Lipoic Acid is generally considered safe for humans, even at high doses, according to multiple studies. However, there have been rare cases of intoxication in children, and its safety in pregnant women has not been extensively studied. ^{6 7 8 9 10}

How does alpha-lipoic acid differ from other treatments for its condition?

Alpha-lipoic acid is unique because it acts as a powerful antioxidant, helping to neutralize harmful molecules in the body and regenerate other antioxidants like vitamins C and E. Unlike many treatments, it is both water and fat soluble, allowing it to work throughout the body, and it has potential benefits for a wide range of conditions, including diabetes, cardiovascular diseases, and neurodegenerative disorders. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Jessica McDermott

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

Inclusion Criteria

You are not suitable for radiation treatment with a total planned dose higher than 30 Gy for long-term or supportive care purposes.

Provision to sign and date the consent form

Stated willingness to comply with all study procedures and be available for the duration of the study

Exclusion Criteria

Women who are pregnant or lactating. Patients of reproductive potential must have a negative serum or urine pregnancy test within 72 hours of start of study drug

Judgement by the investigator that the patient is unsuitable to participate in the study and the patient in unlikely to comply with study procedures, restrictions, and requirements

You are currently taking gabapentin, pregabalin, amitriptyline, nortriptyline, or duloxetine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive alpha lipoic acid during concurrent chemoradiation therapy, with dose escalation in a 3+3 design

6 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival and overall survival assessments

6 months

3 and 6 month follow-up visits

Long-term follow-up

Participants are monitored for overall survival and long-term safety

Up to 18 months

Treatment Details

Interventions

• Alpha Lipoic Acid

Participant Groups

Group I: Alpha Lipoic Acid (ALA) during chemoradiation Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Cancer League of Colorado

Collaborator

Trials

13

Recruited

450+

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Long-term effect of 3-week intravenous alpha-lipoic acid administration in symptomatic diabetic polyneutropathy with clinical manifestations]. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of symptomatic diabetic polyneuropathy with the antioxidant alpha-lipoic acid: a 7-month multicenter randomized controlled trial (ALADIN III Study). ALADIN III Study Group. Alpha-Lipoic Acid in Diabetic Neuropathy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Neuroprotective effect of alpha-lipoic acid and methylprednisolone on the spinal cord ischemia/reperfusion injury in rabbits. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Induction of ER Stress-Mediated Apoptosis by α-Lipoic Acid in A549 Cell Lines. [2021]

5. Romania pubmed.ncbi.nlm.nih.gov

[Possibilities of correcting some metabolic disorders in experimental endotoxic shock by treatment with a combination of alpha-lipoic acid and epsilon aminocaproic acid]. [2013]

6. Italy pubmed.ncbi.nlm.nih.gov

Safety of oral alpha-lipoic acid treatment in pregnant women: a retrospective observational study. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Evaluation of α-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies. [2020]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Alpha Lipoic Acid During 4 Years of Observation: A Retrospective, Clinical Trial in Healthy Subjects in Primary Prevention. [2022]

9. Turkey pubmed.ncbi.nlm.nih.gov

Alpha-lipoic acid intoxication in an adolescent girl: Case report and review of the literature. [2021]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Lipoic acid: physiological role and prospects for clinical application]. [2020]

11. France pubmed.ncbi.nlm.nih.gov

[An endogenous dithiol with antioxidant properties: alpha-lipoic acid, potential uses in cardiovascular diseases]. [2018]

12. Brazil pubmed.ncbi.nlm.nih.gov

Molecular and Therapeutic Insights of Alpha-Lipoic Acid as a Potential Molecule for Disease Prevention. [2023]

13. England pubmed.ncbi.nlm.nih.gov

α-Lipoic acid, functional fatty acid, as a novel therapeutic alternative for central nervous system diseases: A review. [2019]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Lipoic acid - biological activity and therapeutic potential. [2022]