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Berry

BRB Lozenges for Oral Cancer Prevention in Smokers

N/A
Recruiting
Led By Karam P El-Bayoumy, Ph.D
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Smoke 5 cigarettes per day or more for at least the past 12 months
Age 21-75
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of 8-week brb treatment
Awards & highlights

Study Summary

This trial is testing whether black raspberry lozenges can reduce damage from cigarette smoke in the mouths of adult smokers.

Who is the study for?
Adult smokers aged 21-75 who smoke at least 5 cigarettes daily for the past year, with a breath carbon monoxide level over 6 ppm. Participants must be willing to attend study visits for 14 weeks and not plan to quit smoking in that period. Excluded are pregnant/nursing women, those with unstable medical conditions or mental illness, raspberry allergies, heavy drinkers, recent users of drugs or high-dose antioxidants.Check my eligibility
What is being tested?
The trial is testing if black raspberry (BRB) lozenges can reduce DNA damage in mouth cells caused by cigarette smoke. It's designed to see if these lozenges might lower health risks linked to smoking by protecting oral cells from the harmful effects of tobacco.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical reactions related to consuming fruit-based products such as allergies or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been smoking at least 5 cigarettes daily for the past year.
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I am between 21 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of 8-week brb treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of 8-week brb treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of HPB-releasing adducts (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks
Secondary outcome measures
Change of 8-IsoP (urine) from Baseline to end of BRB lozenge treatment at 8 weeks
Change of 8-OXO-dG (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks
Change of Anthocyanin (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: BRB LozengesExperimental Treatment1 Intervention
Oral lozenges that contain 1 gram of BRB freeze-dried powder

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
491 Previous Clinical Trials
2,798,747 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,337 Total Patients Enrolled
7 Trials studying Oral Cancers
1,846 Patients Enrolled for Oral Cancers
Karam P El-Bayoumy, Ph.DPrincipal InvestigatorPenn State University Hershey Medical Center

Media Library

Black Raspberry Lozenges (Berry) Clinical Trial Eligibility Overview. Trial Name: NCT04372914 — N/A
Oral Cancers Research Study Groups: BRB Lozenges
Oral Cancers Clinical Trial 2023: Black Raspberry Lozenges Highlights & Side Effects. Trial Name: NCT04372914 — N/A
Black Raspberry Lozenges (Berry) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04372914 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study currently recruiting participants?

"As reported on clinicaltrials.gov, this medical trial is actively recruiting participants. The study was initiated on October 7th 2021 and last updated November 29th 2022."

Answered by AI

How many subjects are actively contributing to this clinical experiment?

"Affirmative, the clinicaltrials.gov website clearly states that this research project is currently open for enrollment. This trial was initially published on October 7th 2021 and recently amended on November 29th 2022. In total, 58 patients are needed to be registered at a single institution."

Answered by AI

Am I eligible to become a participant in this trial?

"This clinical trial is targeting 58 participants aged 21-75 with evidence of DNA damage. The eligibility criteria includes smoking at least 5 cigarettes/day for 12 months or more, an expired air carbon monoxide measurement >6 parts per million, no serious attempts to quit in the past month and not intending to do so within 4 months from recruitment date, being able to read and write in English, understand and give consent for study procedures, attend all visits during the 14 week period and respond appropriately to research contact between them."

Answered by AI

Does your trial take into account those over 45 years of age?

"Per the information published on this clinical trial, potential candidates must be in between 21 to 75 years old. For those who are below 18 or over 65, there is a special selection of 8 and 145 studies respectively."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~9 spots leftby Sep 2024