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HNSCCPhase 1NCT04042935

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

A Phase 1 study testing Alpha Lipoic Acid in people with HNSCC, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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-metastatic disease. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
HNSCC
What is being tested?
Alpha Lipoic Acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
27 Feb 2020to 24 Sep 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Be a male or female aged 18-100.
  • Histologically or cytologically confirmed stage II-IVB HNSCC of the oral cavity, hypopharynx, oropharynx, larynx, or nasopharynx.
  • Ability to take medication orally or per feeding tube and be willing to adhere to the medication regimen.
  • Patients who are deemed appropriate for definitive, adjuvant, or palliative radiation with total planned dose > 30 Gy.
Show all 11Show fewer
  • Patients who are deemed appropriate for concurrent systemic therapy with radiation including cisplatin (100 mg/m2 triweekly or 30-40 mg/m2 weekly), carboplatin (AUC 1-2 weekly) +/- paclitaxel (30 mg/m2 weekly) or cetuximab (400 mg/m2 loading followed by 250 mg/m2 weekly.
  • The final 3 patients in the dose expansion group undergoing the PK/PD study must be deemed appropriate for cisplatin.
  • For females of reproductive potential: use of highly effective contraception including hormonal contraceptives, intrauterine devices (IUD), vasectomy, tubal ligation, and double barrier methods (combination of male condom, female condom, cervical cap, diaphragm, contraceptive sponge).
  • For males of reproductive potential: use of condoms.
  • ECOG performance status ≤ 2.

Who cannot join

  • Participation in another clinical study with an investigational product during the last 30 days.
  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, a clinical study not involving pharmaceutical or radiation techniques, or during the follow-up period of an interventional study.
  • 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.
  • Patients who are currently taking gabapentin, pregabalin, amitriptyline, nortriptyline, or duloxetine.
  • Known allergy or hyposensitivity to alpha lipoic acid.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Hospital

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Alpha Lipoic Acid to Decrease Treatment Related Pain and Side Effects During Concurrent Chemoradiation in HNSCC

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-metastatic disease.

Read the detailed description

The study will be completed when the MTD and RP2D are determined. This will be either when 2 or more patients have a DLT at a particular dose level, or when 6 patients have completed treatment at the highest dose level (600 mg TID). The final 3 patients enrolled at the highest tolerated dose will also complete PK studies.

Conditions
HNSCC
Being tested
Alpha Lipoic Acid
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alpha Lipoic AcidDrug

    Stage II-IVB HNSCC patients receiving concurrent systemic therapy and radiation in the definitive, adjuvant, or palliative setting will receive ALA according to their prescribed dose level. ALA will be taken orally or per feeding tube. It will start 1 week prior to the start of CRT, continue on through CRT, and then continue for 2 weeks after the completion of CRT. Patients will be given dosing diaries to document date and time of each drug administration as well as any missed doses. They will also have weekly visits to report AEs and concurrent medications, have a history and physical exam, report VAS pain scores and OMAS scores, and fill FACT-HN surveys.

Study groups in NCT04042935
Study groupRoleWhat they receive
Alpha Lipoic Acid (ALA) during chemoradiationExperimentalStage 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.
Receives: Drug: Alpha Lipoic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD and RP2D of ALA during chemoradiotherapy for HNSCC patients

    The maximum tolerated dose will be the highest dose in the planned schema that is given without evidence of SAEs.

    The RP2D will incorporate the MTD and PKs to determine the dose that is best tolerated as well as has the concentration necessary to be effective according to historical studies.

    Measured: 18 months

Secondary outcomes (8)

  1. Safety of ALA by following adverse events (AEs)

    Adverse events will be documented to determine the primary endpoints as well as to categorize potential side effects that can be attributed to ALA. CTCAE version 5.0 will be used to categorize the AEs

    Measured: up to 18 months

  2. Maximum plasma concentration of ALA at the MTD with chemoradiotherapy

    Maximum plasma concentration will be evaluated on the 3 patients in the dose expansion group at the MTD. This will be studied when given with cisplatin for standardization to ensure concentration is similar to when ALA is given alone.

    Measured: At start of ALA, Day 1, and Day 15, for 3 dose expansion PK patients

  3. Change in Oral Mucositis Assessment Scale (OMAS) from baseline

    OMAS scores will give preliminary measures on efficacy of drug to control pain and improve quality of life which will be the primary focus in future studies. Total scores will be collected from 0 (no mucositis) to 45 (worse mucositis). Average OMAS and change from baseline to worst score will be evaluated.

    Measured: From start of treatment to post-treatment surveillance scans, up to 6 months

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

    VAS for pain will give preliminary measures on efficacy of drug to control pain which will be the primary focus in future studies. The VAS score is from 0-10 with 0 being no pain and 10 being the worse possible pain. Average VAS and change from baseline to worst score will be evaluated.

    Measured: From start of treatment to post-treatment surveillance scans, up to 6 months

  5. Change in quality of life measures using the Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) during chemoradiation

    The Functional Assessment of Cancer Therapy - Head \& Neck (FACT-HN) will be used to evaluate quality of life measures at baseline and during treatment. This scale has the sub-categories of physical well being, social/family well-being, emotional well-being, functional well-being, and additional concerns. Each question is scaled from 0 (worst) to 4 (best). Each sub-category will be totaled and a total FACT-HN score will be calculated for each time point. Average sub-category and total scores will be calculated as well as change from baseline to worst scores during treatment.

    Measured: From start of treatment to post-treatment surveillance scans, up to 6 months

  6. Total concurrent opioid use using patient reported diaries

    Patients will document every dose of opioid medications taken during the study period. This will be used to used to calculated total opioid amounts taken (as oxycodone equivalents) as well as total duration of opioid use in days.

    Measured: From start of treatment to post-treatment surveillance scans, up to 6 months

  7. Progression free survival (PFS)

    Progression free survival will be calculated as time to disease progression from start of treatment measured in weeks. This will be documented by PET/CT and/or CT neck and chest completed prior to start of treatment and approximately 3 and 6 months after treatment discontinuation

    Measured: Screening, 3 and 6 month follow up visits

  8. Overall survival (OS)

    OS will be calculated as time from start of treatment to death as measured in weeks. This will be documented by survival follow-up during study visits

    Measured: From start of treatment up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2019
  2. Study start27 Feb 2020
  3. Primary completion19 Feb 2021
  4. Study completion24 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Sequential
Model description
3+3 Dose Escalation: Dose Level -2: ALA 300 mg daily Dose Level -1: ALA 600 mg daily Dose Level 1: ALA 600 mg BID Dose Level 2: ALA 600 mg TID
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04042935
Sponsor's protocol ID
19-1081.cc
Status last verified
Mar 2026
First submitted
26 Jul 2019
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Alpha Lipoic Acid in people with HNSCC, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD and RP2D of ALA during chemoradiotherapy for HNSCC patients (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04042935.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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