Prevention of Oral DNA Damage by Black Raspberries

Learn more about:
Related Clinical Trial
Oral Microbioma and Oral Malignant Disease Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Oropharyngeal Cancer. Radial Forearm Donor Site Closure Oral Cancer Awareness in Egypt Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders Therapeutic Efficacy of Quercetin Versus Its Encapsulated Nanoparticle on Tongue Squamous Cell Carcinoma Cell Line Mandibular Reconstruction Preplanning (ViPMR) the Oncogenic Potential of Salivary miRNA-93 and miRNA-412-3P in Oral Lichen Planus Patients Newer Therapeutic Targets in Head and Neck Cancers Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects. Improved Implant for Reconstruction Purposes After Mandibular Resection Cell-free Tumor DNA in Head and Neck Cancer Patients Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions The Oral Microbiome in OSCC The Link Between Periodontitis, Smoking and Oral Cancer Research on Optimization and Evaluation of Oral Cancer Screening Methods Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings Topical Aldara (Imiquimod) for Oral Cancer Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions LLL Phototherapy in Oral Lesions Resulting From Anti-neoplastic Treatment Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial Understanding Non-radiotherapy-based Development of Trismus Use of Ultrasound for Measuring Size of Oral Tongue Cancers Green Tea Mouthwash on the Oral Health Status in Oral Cancer Patients Oral Cancer Screening and Education in Hong Kong Evaluating Oral Visual Inspection in the Control of Oral Cancer Inductive Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients Effects of EMG Visual Feedback for Spinal Accessory Nerve Dysfunction After Neck Dissection: a Randomized Clinical Trial Prevention of Oral DNA Damage by Black Raspberries Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma NBI in Oral Cavity Cancer Erlotinib and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney, Colorectal, Head and Neck, Pancreatic, or Non-Small Cell Lung Cancer Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer 18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer Physical Activities by Technology Help (PATH) Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC Role of Neo-adjuvant Chemotherapy in Tongue Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients Patient Evaluation for Head and Neck Surgery Branch Studies Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy Prospective Analysis of Robot-Assisted Surgery Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery Extended Follow-Up of Young Women in Costa Rica Who Received Vaccination Against Human Papillomavirus Types 16 and 18 and Unvaccinated Controls Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer Cigarette Smoking and Oral Microbiota Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line The Role of Lymphangiogenesis in Head and Neck Cancer Metastasis Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. MSOT Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis Least Invasive Nonlinear Light Microscopy Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients Improving Access to Control of Diseases for Women IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC Submandibular Gland Preservation in Neck Dissection uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression The Use of Functional Confections in Promoting Oral Health The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma The Study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis. Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions Wild Type p53 Adenovirus for Oral Premalignancies Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions Trial of IIb Preserving Neck Dissection Expression of Hypoxia-Inducible Factor-α in Oral Precancers and Cancers Diagnosis of Oral Precancers and Cancers Using Optic Coherence Tomography Innovative Approach to Triage Oral Precancer The Role of SDF-1/CXCR4 in Metastasis of Oral Squamous Cell Carcinoma Rehabilitation Outcomes in Head and Neck Survivors Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions The Relation of Microtubule-Associated Protein 2 and Cell Migration Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study) Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue Oral Pathology Asynchronous Telementoring Pilot Study Polarized Reflectance Spectroscopy for Oral Lesions A Study of the Effects of PEITC on Oral Cells With Mutant p53 Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma The Role of microRNA-29b in the Oral Squamous Cell Carcinoma Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer – COOLS TRIAL Assessment of Mandibular Bone Invasion With MRI Using SWIFT Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients Epstein-Barr Detection in Oral Cancer Workplace Tobacco Cessation And Oral Cancer Screening Study Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral Cancer Cancer. Elective vs Therapeutic Neck Dissection in Treatment of Early Node Negative Squamous Carcinoma of Oral Cavity Personalized Survivor Care Plan for Oral Cancer Patients-Effects on Physical-Psychological Functions and Return-to-Work Dental Hygienists and Dentists as Providers of Oral Mucosa Screening and Brush Biopsies Effects of Mouth-opening Training on the Maximum Interincisal Opening Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy – 3-years Prospective Study Erlotinib Prevention of Oral Cancer (EPOC) Oral Cancer Screening in Mumbai, India by Primary Health Care Workers Study on the Carcinogenesis of Gα12 in Oral Cancer, and the Treatment of Oral Cancer Using Ga12 Inhibitor. The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer. Validation of DNA Methylation Biomarkers for Oral Cancer Detection Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention Expression of VEGF-C and VEGF-CR in Oral Cancers and Premalignant Lesions PET/CT and Sentinel Node in Oral Cancer Validation of DNA Methylation Biomarkers for Oral Cancer Detection Web-based Education on Oral Cancer for Primary Care Physicians in Ohio Analysis Of Sensory Recovery Of Donor Size And Quality Life In Oral Cancer Patients Using an APP in Post Oral Cancer Surgery to Affect Patients’ Needs and Quality of Life.

Brief Title

Prevention of Oral DNA Damage by Black Raspberries

Official Title

Effect of Oral Black Raspberry Administration on Oral Cell DNA Adducts in Smokers

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 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 Type

Interventional


Primary Outcome

Change of HPB-releasing adducts (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks

Secondary Outcome

 Change of B[a]P adducts (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks

Condition

Oral Cancer

Intervention

BRB Lozenges

Study Arms / Comparison Groups

 BRB Lozenges
Description:  Oral lozenges that contain 1 gram of BRB freeze-dried powder

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

58

Start Date

October 7, 2021

Completion Date

September 2024

Primary Completion Date

September 2024

Eligibility Criteria

        Inclusion Criteria:

          -  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 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
      

Gender

All

Ages

21 Years - 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

John P Richie, Ph.D, 7175317178, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04372914

Organization ID

STUDY00013621

Secondary IDs

R01CA173465

Responsible Party

Principal Investigator

Study Sponsor

Milton S. Hershey Medical Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

John P Richie, Ph.D, Principal Investigator, Penn State University Hershey Medical Center


Verification Date

November 2022