Alpha Lipoic Acid for the Reduction of Treatment Related Pain and Side Effects During Chemoradiation in Patients with Stage II-IVB Head and Neck Squamous Cell Cancer

Inclusion Criteria

• 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
• 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/m^2 triweekly or 30-40 mg/m^2 weekly), carboplatin (area under curve [AUC] 1-2 weekly) +/- paclitaxel (30 mg/m^2 weekly) or cetuximab (400 mg/m^2 loading followed by 250 mg/m^2 weekly * The final 3 patients in the dose expansion group undergoing the PK/pharmacodynamics (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
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Exclusion Criteria

• 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