Investigating how acetaldehyde contributes to oral cancer development

Dissecting the Role of Acetaldehyde in Oral Carcinogenesis

This study is trying to see how drinking alcohol affects the development of oral cancer in healthy people and those with Fanconi anemia by looking at samples like saliva and urine.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Masonic Cancer Center, University of Minnesota (Academic / other)
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT05973656 on ClinicalTrials.gov

What this trial studies

This intervention involves healthy volunteers and individuals with Fanconi anemia consuming a single dose of alcohol to study the role of acetaldehyde in oral cancer development. Participants will provide non-invasive biological samples, including saliva, oral cells, and urine, at various time points. Optional blood samples will also be collected for future research. The study aims to understand the biological effects of alcohol consumption on individuals with different genetic backgrounds related to alcohol metabolism.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 21-45 who consume alcohol occasionally or individuals aged 18-45 with Fanconi anemia who have not consumed alcohol in the last six months.

Not a fit: Patients with a history of alcohol or drug-related problems or those currently taking medications that affect alcohol metabolism may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of the mechanisms behind oral cancer development, potentially leading to better prevention strategies.

How similar studies have performed: While the specific approach of this study may be novel, similar studies investigating the effects of alcohol on cancer development have shown promising results.

Eligibility criteria

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

Where this trial is running

Minneapolis, Minnesota

• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Balbo Silvia, PhD

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