Prevention of Oral DNA Damage by Black Raspberries

  • STATUS
    Recruiting
  • End date
    Sep 7, 2024
  • participants needed
    58
  • sponsor
    Milton S. Hershey Medical Center
Updated on 7 December 2021
Accepts healthy volunteers

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.

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.

Details
Condition Head and Neck Cancer, Physiological Stress, Oral Cancer, Smoking, Oral Neoplasm, Stress, oral cancers, dna damages, Oral Cavity Cancer, head and neck cancer, DNA Damage, Oxidative Stress
Treatment BRB Lozenges
Clinical Study IdentifierNCT04372914
SponsorMilton S. Hershey Medical Center
Last Modified on7 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 21-65
Smoke 15 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 Criteria

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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