Oral CancerNCT04372914
Prevention of Oral DNA Damage by Black Raspberries
A study testing BRB Lozenges in people with Oral Cancer and Smoking, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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 adult smokers, which may be useful in reducing health risks associated with smoking. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Smoking, DNA Damage
- What is being tested?
- BRB Lozenges
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State CTSI Clinical Research Center
Hershey, Pennsylvania, 17033
About this study
Official title: Effect of Oral Black Raspberry Administration on Oral Cell DNA Adducts in Smokers
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 adult smokers, which may be useful in reducing health risks associated with smoking.
Read the 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 period. Prior to study enrollment, all participants will have an Oral Cancer screening intraoral exam and persons with oral pathology (e.g. premalignant or oral squamous cell carcinoma) will be referred for appropriate clinical care. Biological samples will be collected at 0, 1, 4, 5, 8, 9, 12 and 13 weeks. An 8-week BRB administration period was selected to allow for ample time for effects to be observed in the major endpoints, based on previous clinical data. Likewise, a 4 week washout period at the end of the trial will allow for effects of BRB withdrawal on major outcomes to be measured.
A total of 58 healthy subjects will be recruited into this intervention study. Eligible subjects, after phone screening, will visit the clinic for an additional in-person screening which includes measurement of expired carbon monoxide and pregnancy test (females). Prior to enrollment, each subject will be offered a free oral cancer screening. After obtaining informed consent, eligible subjects will be administered a questionnaire to obtain information on basic demographics, medical history, lifestyle, tobacco and alcohol consumption, and usual dietary intake and biological samples (exfoliated buccal cells and urine) and anthropometric data (e.g. height and weight) will be collected. Subjects will be asked to return after 1 week (Visit 2, 2nd baseline visit) and biological samples will be collected. Subjects will be provided their first supply of test agent (BRB lozenge) and a usage diary and instructed on the proper method for application and completion of the diary entries. At Visits 3-6 (weeks 4, 5, 8, and 9, respectively) subjects will return any unused product, receive a new batch of lozenges (except for week 9), complete a brief questionnaire on compliance and provide biological samples. At week 9 (Visit 6), subjects will return their study diaries and enter the washout period where no test agent will be provided. At the final visits (Visit 7 and 8, weeks 12 and 13), subjects will provide biological samples.
- Conditions
- Oral Cancer, Smoking, DNA Damage, Oxidative Stress
- Being tested
- BRB Lozenges
- Medical subject headings
- Mouth Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRB LozengesDietary supplement
Each lozenge is made from 1 gram of freeze-dried black raspberry powder (equivalent to ~5 black raspberries) in the form of a dissolvable slow-release lozenge.
| Study group | Role | What they receive |
|---|---|---|
| BRB Lozenges | Experimental | Oral lozenges that contain 1 gram of BRB freeze-dried powder Receives: Dietary Supplement: BRB Lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPB-releasing Adducts (Buccal Cells)
The tobacco specific nitrosamine, N'-nitrosonornicotine, is metabolically activated to form DNA adduct that upon hydrolysis releases 4-hydroxy-1-(3-pyridyl)-1-butonone (HPB), which was measured in buccal cells of smokers in picogram per microgram guanine (one of the four bases of DNA).
Measured: 8 weeks
Secondary outcomes (5)
B[a]P Adducts (Buccal Cells)
Benzo[a]pyrene, a tobacco smoke constituent, is metabolized in buccal cells of smoker's into active metabolite namely benzo[a]pyrene-diol epoxide (BPDE). BPDE can react with DNA to form deoxyguanosine adducts (BPDE-N^2-dG) that measured in buccal cells of smokers in picogram per microgram deoxyguanosine.
Measured: 8 weeks
8-OXO-dG (Buccal Cells)
Cigarette smoke is a rich source of free radicals that can promote oxidative stress and carcinogenesis, including head and neck squamous cell carcinoma. 8-oxo-7,8-dihydro-2'deoxyguanosine (8-oxo-dG) is a valid biomarker of oxidative stress. We measured 8-oxo-dG in buccal cells of smokers and the levels are expressed as picogram per microgram of deoxyguanosine.
Measured: 8 weeks
Cotinine (Urine)
Biomarker of tobacco smoke exposure
Measured: 8 weeks
Creatinine (Urine)
Biomarker of urine dilution
Measured: 8 weeks
8-Isoprostane (Urine)
Biomarker of systemic oxidative stress
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start7 Oct 2021
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Karam El-Bayoumy, Milton S. Hershey Medical Center
- Investigators
- Karam P El-Bayoumy, Ph.D, Principal investigator, Penn State University Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372914
- Sponsor's protocol ID
- STUDY00013621
- Other IDs
- R01CA173465
- Status last verified
- Feb 2026
- First submitted
- 22 Apr 2020
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Black Raspberry Administration on Oral Cell DNA Adducts in Smokers
- ClinicalTrials.gov ID
- NCT04372914
- Acronym / sponsor ID
- STUDY00013621
- Conditions
- Oral Cancer, Smoking, DNA Damage, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 adult smokers, which may be useful in reducing health risks associated with smoking.
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 period. Prior to study enrollment, all participants will have an Oral Cancer screening intraoral exam and persons with oral pathology (e.g. premalignant or oral squamous cell carcinoma) will be referred for appropriate clinical care. Biological samples will be collected at 0, 1, 4, 5, 8, 9, 12 and 13 weeks. An 8-week BRB administration period was selected to allow for ample time for effects to be observed in the major endpoints, based on previous clinical data. Likewise, a 4 week washout period at the end of the trial will allow for effects of BRB withdrawal on major outcomes to be measured.
A total of 58 healthy subjects will be recruited into this intervention study. Eligible subjects, after phone screening, will visit the clinic for an additional in-person screening which includes measurement of expired carbon monoxide and pregnancy test (females). Prior to enrollment, each subject will be offered a free oral cancer screening. After obtaining informed consent, eligible subjects will be administered a questionnaire to obtain information on basic demographics, medical history, lifestyle, tobacco and alcohol consumption, and usual dietary intake and biological samples (exfoliated buccal cells and urine) and anthropometric data (e.g. height and weight) will be collected. Subjects will be asked to return after 1 week (Visit 2, 2nd baseline visit) and biological samples will be collected. Subjects will be provided their first supply of test agent (BRB lozenge) and a usage diary and instructed on the proper method for application and completion of the diary entries. At Visits 3-6 (weeks 4, 5, 8, and 9, respectively) subjects will return any unused product, receive a new batch of lozenges (except for week 9), complete a brief questionnaire on compliance and provide biological samples. At week 9 (Visit 6), subjects will return their study diaries and enter the washout period where no test agent will be provided. At the final visits (Visit 7 and 8, weeks 12 and 13), subjects will provide biological samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRB Lozenges | Experimental | Dietary Supplement: BRB LozengesOral lozenges that contain 1 gram of BRB freeze-dried powder |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRB LozengesEach lozenge is made from 1 gram of freeze-dried black raspberry powder (equivalent to ~5 black raspberries) in the form of a dissolvable slow-release lozenge. | Dietary supplement | BRB Lozenges |
Primary outcome
HPB-releasing Adducts (Buccal Cells)
Time frame: 8 weeks
The tobacco specific nitrosamine, N'-nitrosonornicotine, is metabolically activated to form DNA adduct that upon hydrolysis releases 4-hydroxy-1-(3-pyridyl)-1-butonone (HPB), which was measured in buccal cells of smokers in picogram per microgram guanine (one of the four bases of DNA).
5 secondary outcomes
B[a]P Adducts (Buccal Cells)
Time frame: 8 weeks
8-OXO-dG (Buccal Cells)
Time frame: 8 weeks
Cotinine (Urine)
Time frame: 8 weeks
Creatinine (Urine)
Time frame: 8 weeks
8-Isoprostane (Urine)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karam P El-Bayoumy, Ph.D principal investigator
Penn State University Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRB Lozenges in people with Oral Cancer and Smoking, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPB-releasing Adducts (Buccal Cells) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.