Role of Acetaldehyde in the Development of Oral Cancer

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05973656
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 170
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 61.8
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol-Related Carcinoma; Fanconi Anemia; Oral Cavity Carcinoma	Drug: Alcohol; Procedure: Biospecimen Collection; Procedure: Breath Test	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 170 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Dissecting the Role of Acetaldehyde in Oral Carcinogenesis
• Actual Study Start Date: Jul 8, 2022
• Anticipated Primary Completion Date: Sep 1, 2026
• Anticipated Study Completion Date: Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I (alcohol consumption) 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.	Drug: Alcohol; Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).; Procedure: Biospecimen Collection; Undergo saliva, mouthwash, and cheek brush collection; Procedure: Breath Test; Undergo breathalyzer testing
Active Comparator: Group II (biospecimen collection) Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.	Procedure: Biospecimen Collection; Undergo saliva, mouthwash, and cheek brush collection; Procedure: Breath Test; Undergo breathalyzer testing

Outcome Measures

Primary Outcome Measures

1. Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose [Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose]

   Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples).

Secondary Outcome Measures

1. Urine will be analyzed to confirm non-smoking status [Prior to alcohol exposure]

   The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine.

2. Urine will be analyzed to confirm non-smoking status [Up to 6 hours after alcohol exposure]

   The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 - ALDH21/1 homozygotes-not of Eastern Asian decent;

• Healthy volunteer - ALDH21/2 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota
• National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT05973656
• Other Study ID Numbers: SPH-2021-29712; NCI-2022-09710
• First Posted: Aug 3, 2023
• Last Update Posted: Aug 3, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Fanconi Syndrome; Fanconi Anemia

Study Results

No Results Posted as of Aug 3, 2023