Role of Acetaldehyde in the Development of Oral Cancer

Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · Jul 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the role of a substance called acetaldehyde in the development of oral cancer. Researchers want to learn more about how alcohol consumption may affect the risk of developing this type of cancer. The study will involve healthy volunteers and individuals with a genetic condition called Fanconi anemia. Participants will consume a single dose of alcohol and provide samples of saliva, oral cells (using mouthwash and cheek brushes), and urine at different times. There’s also an option to provide a couple of blood samples for future research.

To be eligible for this trial, participants should be between 21 and 45 years old and consume alcohol occasionally (at least one drink per month for healthy volunteers or one drink in the last three months for those with Fanconi anemia). Non-drinkers aged 18 to 45 who have never consumed alcohol or haven't had any in the last six months can also join. It's important to note that people who are pregnant, nursing, or have certain health issues related to alcohol use or smoking cannot participate. Those who take medications that could interfere with alcohol or have had recent infections will also be excluded. Participants can expect a safe and supportive environment while contributing to important research that may help improve understanding of oral cancer risks.

Gender

ALL

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