Role of Acetaldehyde in the Development of Oral Cancer

University of Minnesota (UMN)

Status: Enrolling

Conditions: Fanconi Anemia; Alcohol-Related Carcinoma; Oral Cavity Carcinoma

Treatments: Procedure: Breath Test; Procedure: Biospecimen Collection; Drug: Alcohol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05973656

NCI-2022-09710 (Registry Identifier)

SPH-2021-29712

Details and patient eligibility

About

This is a minimal risk intervention study where healthy volunteers and individuals with Fanconi anemia will consume a single dose of alcohol and provide primarily non-invasive biological samples at various time points. Biospecimens to be collected include saliva, oral cells collected via mouthwash and cheek brush, and urine. The collection of two blood samples (5 mL each) will be optional and banked for future use.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 21-45 years of age for alcohol drinkers
• Occasionally consume alcohol
• At least 1 drink per month for healthy volunteers
• At least 1 drink in the last 3 months for Fanconi anemia patients
• Meets one of the three criteria
• Healthy volunteer - ALDH2*1/1* homozygotes-not of Eastern Asian decent;
• Healthy volunteer - ALDH2*1/2* heterozygotes-of Eastern Asian decent and experience flushing when drinking
• Individual's with Fanconi anemia (FA).
• 18-45 years of age for non-drinkers
• Never consume alcohol/not had alcohol in the last 6 months
• Healthy volunteers.
• Non-smoker (smoked < 100 cigarettes in a lifetime)

Exclusion criteria

• Pregnant or nursing
• Taking any medication or drug that might affect alcohol use and absorption or that might be affected by alcohol consumption
• Healthy volunteers who have taken any antibiotics in the last 3 months
• Currently consuming more than 21 drinks per week
• Have any history of alcohol or drug related problems
• Current or former tobacco/nicotine product(s) user
• Any regular use of tobacco/nicotine products or marijuana in the last year (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco)
• "Trying" or limited use of any nicotine products or marijuana in the last 1 month
• Active infection (influenza, cold, COVID, respiratory / sinus infection) - admission in the study will be delayed pending improved health
• Non-FA volunteers who have an unstable medical condition or condition that could be affected by alcohol consumption (insulin-dependent diabetes, ulcers, heart issues)
• Experience severe adverse events (nausea, blacking out) when consuming even low doses of alcohol

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Group I (alcohol consumption)

Experimental group

Description:

Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.

Treatment:

Drug: Alcohol

Procedure: Breath Test

Procedure: Biospecimen Collection

Group II (biospecimen collection)

Active Comparator group

Description:

Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.

Treatment:

Procedure: Breath Test

Procedure: Biospecimen Collection