Could a common supplement ease cancer treatment pain?
NCT ID NCT04042935
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested whether alpha lipoic acid, a dietary supplement, can reduce pain and side effects in people with head and neck cancer undergoing chemoradiation. Only 5 patients were enrolled to find a safe and tolerable dose. The goal was to see if it's worth studying further, not to prove it works.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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5 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Sep 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Colorado Hospital
Aurora, Colorado, 80045, United States
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Other studies related to the condition(s) this trial covers.
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