Alcohol Exposure for Oral Cancer Risk

Overseen By Balbo Silvia, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Masonic Cancer Center, University of Minnesota

Must not be taking: Antibiotics, others

Disqualifiers: Pregnancy, Alcoholism, Tobacco use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a single dose of alcohol (ethanol or ethyl alcohol) affects the body, focusing on oral cancer risk. Researchers will collect samples such as saliva and oral cells from healthy volunteers and individuals with Fanconi anemia. Participants will either consume alcohol or provide samples without drinking. Suitable candidates include healthy individuals who occasionally drink alcohol and those with Fanconi anemia who do not drink regularly. Non-smokers fitting these profiles may participate. As an unphased trial, participants can contribute to significant research without the risks linked to new treatments.

Will I have to stop taking my current medications?

The trial requires that you do not take any medication or drug that might affect alcohol use and absorption or that might be affected by alcohol consumption. If you are on such medications, you may need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that drinking alcohol can increase the risk of certain cancers, such as mouth cancer. However, in this study, participants will consume only a small amount of alcohol—just one drink—to reach a specific blood alcohol level. This low amount is commonly used in research to study alcohol's effects.

In terms of safety, one drink doesn't pose serious health risks for most people. However, no amount of alcohol is completely risk-free, especially with regular or heavy consumption. For this study, researchers will analyze participants' saliva and breath, and some may choose to provide a small blood sample. These tests are simple and usually easy for participants.

If there are any safety concerns, especially for those with health issues, consulting a doctor before joining the study is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how alcohol exposure might affect oral cancer risk in a novel way. Unlike standard treatments, which focus on eradicating cancer cells through surgery, radiation, or chemotherapy, this trial investigates the role of alcohol consumption and its immediate biological impacts, such as changes in saliva and breath alcohol concentration. By understanding these mechanisms, researchers hope to identify new biomarkers or risk factors for oral cancer, potentially leading to better prevention strategies.

What evidence suggests that this trial's treatments could be effective for assessing oral cancer risk?

Research has shown that drinking alcohol is linked to a higher risk of certain cancers, such as those in the mouth and throat. One study found that even moderate drinking can increase the chance of oral cancer. For heavy drinkers, the risk rises further. This trial will compare two groups: Group I, where participants consume alcohol, and Group II, where participants abstain from alcohol but undergo biospecimen collection. Alcohol can also reduce the effectiveness of cancer treatments and cause additional complications. These findings suggest that alcohol significantly impacts cancer risk and treatment outcomes. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy volunteers and individuals with Fanconi anemia who occasionally drink alcohol. Participants should be non-smokers, aged 18-45 (21-45 for drinkers), and not have used antibiotics or experienced severe reactions to alcohol recently. Pregnant or nursing individuals, heavy drinkers, those with unstable health conditions affected by alcohol, or recent tobacco/nicotine users are excluded.

Inclusion Criteria

You drink alcohol at least once a month.

You have consumed at least one alcoholic drink in the past three months and have Fanconi anemia.

I am either a healthy volunteer with specific genetic traits, of Eastern Asian descent with alcohol flushing, or have Fanconi anemia.

Exclusion Criteria

You are currently drinking more than 21 drinks per week.

I currently do not have any active infections like the flu, cold, or COVID.

I am healthy but have taken antibiotics in the past 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants consume a single dose of alcohol and provide non-invasive biological samples at various time points

1 day

1 visit (in-person)

Sample Collection

Collection of saliva, oral cells via mouthwash and cheek brush, and urine at specified time points

6 hours

Multiple time-point collections during the visit

Follow-up

Participants are monitored for safety and effectiveness after intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol
• Biospecimen Collection
• Breath Test

Trial Overview

The study investigates how acetaldehyde contributes to oral cancer development after consuming a single dose of alcohol. It involves collecting saliva, mouthwash cells, cheek brush cells, urine samples from participants at different times post-consumption. Blood sample collection is optional.

How Is the Trial Designed?

Group I: Group I (alcohol consumption) Experimental Treatment 3 Interventions

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.

Group II: Group II (biospecimen collection) Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

This study found that using alcohol-containing mouthwashes significantly increases acetaldehyde levels in saliva, reaching concentrations similar to those found after consuming alcoholic beverages, with peak levels observed at 2 minutes post-use.

While the overall systemic exposure to acetaldehyde from mouthwash use is low and poses a minimal public health risk, the local concentrations in the mouth could potentially lead to DNA damage and increase the risk of oral cancer, raising concerns about their long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salivary acetaldehyde increase due to alcohol-containing mouthwash use: a risk factor for oral cancer. Lachenmeier, DW., Gumbel-Mako, S., Sohnius, EM., et al.[2016]

Individuals with aldehyde dehydrogenase 2 deficiency, known as 'flushers', exhibit significantly higher levels of acetaldehyde in their breath after rinsing their mouths with alcohol compared to nonflushers, indicating a potential risk for increased mutagenic DNA lesions.

The study found that even without alcohol ingestion, local exposure to alcohol in the mouth leads to elevated acetaldehyde levels in flushers, which may contribute to a higher risk of head and neck cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Alcohol Sensitivity in Healthy Young Adults on Breath Pharmacokinetics of Acetaldehyde After Mouth Washing with Alcohol. Himemiya-Hakucho, A., Tanaka, T., Liu, J., et al.[2019]

Short-term exposure to ethanol concentrations between 10% and 15% can cause significant cytotoxic effects on human epithelial cells, which may explain the local carcinogenic effects of alcohol in tissues like the oral cavity and esophagus.

To reduce the risk of cancers associated with alcohol consumption, it may be beneficial to choose alcoholic beverages with lower ethanol concentrations or dilute drinks to non-cytotoxic levels, potentially also mitigating the combined risks of alcohol and tobacco use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avoiding the ingestion of cytotoxic concentrations of ethanol may reduce the risk of cancer associated with alcohol consumption. Guillén-Mancina, E., Calderón-Montaño, JM., López-Lázaro, M.[2018]

Sipping strong alcoholic beverages, especially those high in acetaldehyde like calvados, leads to significantly higher salivary acetaldehyde concentrations compared to beverages without acetaldehyde, indicating immediate carcinogenic exposure.

This study found that carcinogenic levels of acetaldehyde can persist in saliva for at least 10 minutes after consumption, highlighting the potential risks associated with even small amounts of strong alcoholic drinks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single sip of a strong alcoholic beverage causes exposure to carcinogenic concentrations of acetaldehyde in the oral cavity. Linderborg, K., Salaspuro, M., Väkeväinen, S.[2013]

Smokers have significantly higher levels of salivary acetaldehyde after consuming alcohol compared to nonsmokers, indicating that smoking increases the carcinogenic potential of alcohol consumption.

When smokers also smoke while drinking alcohol, their salivary acetaldehyde levels rise dramatically, suggesting a synergistic effect that may contribute to a higher risk of upper digestive tract cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic effect of alcohol drinking and smoking on in vivo acetaldehyde concentration in saliva. Salaspuro, V., Salaspuro, M.[2016]

In a study involving 10 healthy nonsmokers, levels of the DNA adduct N(2)-ethylidene-dGuo increased significantly (up to 100-fold) within 4 hours after alcohol consumption, indicating a strong dose-responsive relationship with acetaldehyde exposure.

These findings provide important evidence of how alcohol consumption leads to DNA damage in oral cells, supporting the link between acetaldehyde and the risk of head and neck cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinetics of DNA adduct formation in the oral cavity after drinking alcohol. Balbo, S., Meng, L., Bliss, RL., et al.[2021]

Acetaldehyde, a byproduct of alcohol consumption and a known group 1 carcinogen, significantly increases the risk of upper gastrointestinal cancers, especially in individuals with certain genetic mutations affecting alcohol metabolism.

Preventive measures can effectively reduce acetaldehyde exposure, highlighting the importance of regulatory actions and consumer education in cancer prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactions of alcohol and tobacco in gastrointestinal cancer. Salaspuro, M.[2017]

Moderate ethanol ingestion leads to significant production of acetaldehyde in saliva, which may contribute to the increased risk of upper gastrointestinal tract cancer, as acetaldehyde is known to be mutagenic and carcinogenic.

The study found that using an antiseptic mouthwash (chlorhexidine) for three days significantly reduced acetaldehyde production, suggesting that oral hygiene may play a role in mitigating the cancer risk associated with alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High acetaldehyde levels in saliva after ethanol consumption: methodological aspects and pathogenetic implications. Homann, N., Jousimies-Somer, H., Jokelainen, K., et al.[2022]

Citations

1.

hhs.gov

hhs.gov/sites/default/files/oash-alcohol-cancer-risk.pdf

Alcohol and Cancer Risk 2024

For certain cancers, like breast, mouth, and throat cancers, evidence shows that this risk may start to increase around one or fewer drinks per day. This ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10415957/

Alcohol Consumption Among Adults With a Cancer ...

In addition, alcohol is associated with worsened treatment outcomes, such as decreased effectiveness and increased risk of complications.

3.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13694-z

Effect of alcohol consumption on oncological treatment ...

Alcohol consumption has been associated with an increased risk of cancer-related mortality. It may also negatively impact oncological therapies.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1368837510001363

A meta-analysis of alcohol drinking and oral ...

This meta-analysis provides more precise evidence of a gross excess of OPC risk for heavy alcohol drinkers. It also indicates an increased risk for moderate ...

5.

cancer.gov

cancer.gov/about-cancer/causes-prevention/risk/alcohol/alcohol-fact-sheet

Alcohol and Cancer Risk Fact Sheet - NCI

A fact sheet that summarizes the evidence linking alcohol consumption to the risk of various cancers. Includes information about factors ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6982979/

Alcohol-based mouthwash as a risk factor of oral cancer

It cannot be guaranteed that the use of mouthwash represents an independent risk factor for the development of head and neck cancer.

7.

who.int

who.int/europe/news/item/04-01-2023-no-level-of-alcohol-consumption-is-safe-for-our-health

No level of alcohol consumption is safe for our health

The risk of developing cancer increases substantially the more alcohol is consumed. However, latest available data indicate that half of all ...

8.

aacrjournals.org

aacrjournals.org/cebp/article/10/11/1137/164025/Oral-Squamous-Cell-Cancer-Risk-in-Relation-to

Oral Squamous Cell Cancer Risk in Relation to Alcohol ...

Heavy alcohol consumption, particularly in combination with cigarette smoking, increases the risk of oral squamous cell carcinoma (OSCC).