Alpha Lipoic Acid for Head and Neck Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether alpha lipoic acid, a dietary supplement, can reduce pain and side effects for people with head and neck cancer undergoing chemotherapy and radiation. Researchers aim to determine if the treatment makes cancer treatment more manageable. Individuals with stage II-IVB head and neck cancer receiving standard chemotherapy and radiation might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that alpha lipoic acid is likely to be safe for humans?

Research shows that alpha lipoic acid is usually well-tolerated. Previous studies found that taking alpha lipoic acid can reduce pain and improve quality of life during cancer treatment. In other research, patients took doses up to 600 mg twice a day without serious side effects.

This trial remains in the early stages, so the researchers are gathering more safety information. However, the use of alpha lipoic acid in other contexts suggests it is safe for most people. Like any treatment, there might be some risks or minor side effects. These early trials are designed to carefully monitor and address any such issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for head and neck squamous cell carcinoma (HNSCC), which typically involve chemotherapy and radiation, Alpha Lipoic Acid (ALA) is being explored for its potential to reduce pain and side effects during these treatments. ALA is unique because it's an antioxidant that can protect cells from damage, possibly leading to fewer side effects. Researchers are excited about ALA because it might improve patient comfort and quality of life while undergoing aggressive cancer therapies. Furthermore, its use in a dose-escalation format allows for finding the optimal balance between effectiveness and safety, which is crucial for enhancing treatment outcomes.

What evidence suggests that alpha lipoic acid might be an effective treatment for HNSCC?

This trial will evaluate the effects of alpha lipoic acid (ALA) during chemoradiation for patients with head and neck cancer. Studies have shown that ALA might slow the growth of head and neck cancer cells. Research also suggests that ALA can reduce the severity of oral mucositis, painful mouth sores often caused by cancer treatments like radiation. Additionally, ALA has antioxidant properties that help protect cells from damage during treatment. While more research is needed, these early findings suggest that ALA could benefit patients undergoing chemotherapy and radiation. ^{1 2 3 6 7}

Who Is on the Research Team?

Jessica McDermott

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Alpha Lipoic Acid

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04042935

Alpha Lipoic Acid to Decrease Pain and Side Effects in ... This is a phase I, single-center, non-randomized, 3+3 dose-escalation study of alpha lipoic acid given during chemotherapy-radiation in HNSCC patients with non- ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12150517/

Differential effects of short-chain fatty acids on head and neck ... Conclusions: Short-chain fatty acids have variable effects on HNSCC cells. Arginine butyrate and alpha-lipoic acid are the most effective in suppressing growth ...

3. withpower.com withpower.com/trial/phase-1-squamous-cell-carcinoma-of-head-and-neck-10-2019-340f9

Alpha Lipoic Acid to Decrease Pain and Side Effects ... This trial is testing alpha lipoic acid, an antioxidant supplement, in patients with head and neck cancer who are receiving treatment.

4. clinconnect.io clinconnect.io/trials/NCT05023863

The Effect of Alpha Lipoic Acid on the Incidence and The effect of alpha lipoic acid on the incidence and severity of radiotherapy-induced oral mucositis in head and neck cancer patients.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05023863/the-effect-of-alpha-lipoic-acid-on-the-incidence-and-severity-of-radiotherapy-induced-oral-mucositis-in-head-and-neck-cancer-patients

The Effect of Alpha Lipoic Acid on the Incidence and ... The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients · Phase.

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-08092

Alpha Lipoic Acid for the Reduction of Treatment Related ... Alpha lipoic acid may alleviate pain and improve the quality of life in patients with head and neck squamous cell cancer while undergoing chemoradiation.

7. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05023863/

Trial | NCT05023863 35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout ...