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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 1

Conditions: HNSCC

Treatments: Drug: Alpha Lipoic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04042935

19-1081.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision to sign and date the consent form.

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

3. Be a male or female aged 18-100.

4. Histologically or cytologically confirmed stage II-IVB HNSCC of the oral cavity, hypopharynx, oropharynx, larynx, or nasopharynx.

5. Ability to take medication orally or per feeding tube and be willing to adhere to the medication regimen.

6. Patients who are deemed appropriate for definitive, adjuvant, or palliative radiation with total planned dose > 30 Gy.

7. 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.

8. 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).

9. For males of reproductive potential: use of condoms.

10. ECOG performance status ≤ 2.

Exclusion criteria

1. Participation in another clinical study with an investigational product during the last 30 days.
2. 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.
3. 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.
4. Patients who are currently taking gabapentin, pregabalin, amitriptyline, nortriptyline, or duloxetine.
5. Known allergy or hyposensitivity to alpha lipoic acid.
6. 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 design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Alpha Lipoic Acid (ALA) during chemoradiation

Experimental group

Description:

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:

Drug: Alpha Lipoic Acid