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

NCT04042935 | Completed Phase 1 FDA Drug

• 1 other identifier: 19-1081.cc
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HNSCC

Outcome Measures

Primary Outcomes (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.

  18 months

Secondary Outcomes (8)

• Safety of ALA by following adverse events (AEs)

  up to 18 months

• Maximum plasma concentration of ALA at the MTD with chemoradiotherapy

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

• Change in Oral Mucositis Assessment Scale (OMAS) from baseline

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

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

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

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

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

Study Arms (1)

Alpha Lipoic Acid (ALA) during chemoradiation

EXPERIMENTAL

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.

Drug: Alpha Lipoic Acid

Interventions

Alpha Lipoic Acid DRUG

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.

Alpha Lipoic Acid (ALA) during chemoradiation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• a. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cancer League of Colorado: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Jessica McDermott

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 2, 2019
• Study Start: February 27, 2020
• Primary Completion: February 19, 2021
• Study Completion: September 24, 2021
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)