Status:
COMPLETED
Prevention of Oral DNA Damage by Black Raspberries
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Oral Cancer
Smoking
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The purpose of this voluntary research study is to learn about the potential effects that black raspberry (BRB) lozenges may have on reducing the damage caused from cigarette smoke in mouth cells in a...
Detailed Description
This clinical trial will consist of a single arm, where participants, after a 1-week baseline period, will be placed on daily BRB administration for a period of 8 weeks followed by a 4 week washout pe...
Eligibility Criteria
Inclusion
- Age 21-75
- Smoke 5 cigarettes per day or more for at least the past 12 months
- Have an expired air carbon monoxide measurement of greater than 6 parts per million
- No serious quit attempt in the last one month and not planning to quit in the next 4 months
- Willing and able to attend all study visits
- Able to read and write in English
- Able to understand and provide consent to the study procedures
- Willingness and ability to attend regular visits over a 14-week period and to respond to research contacts between the 5
Exclusion
- Unstable or significant medical conditions that affect participant safety or biomarker data in the past 3 months (e.g. recent heart attack, asthma or COPD)
- Women currently pregnant or nursing
- Use of any non-cigarette nicotine delivery product in the past 7 days (e.g. e-cigarettes, pipe or cigar)
- Uncontrolled mental illness or inpatient treatment in the past 6 months; current suicide risk on clinical assessment
- Any known allergy to raspberries
- Use of marijuana or other illegal drugs daily or weekly in the past 3 months
- Use of high dose antioxidant supplements in the past month
- Use of antibiotics
- Heavy drinking (\>4 drinks/day, 5 days/week)
- Made no serious cigarette smoking quit attempt or have used any FDA-approved smoking cessation medication in the prior 30 days
- No plan to quit smoking within the next 4 months
Key Trial Info
Start Date :
October 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04372914
Start Date
October 7 2021
End Date
December 6 2024
Last Update
January 29 2025
Active Locations (1)
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1
Penn State CTSI Clinical Research Center
Hershey, Pennsylvania, United States, 17033