Neoplasms

Symptoms and General Pathology

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinogenesis

Mouth Neoplasms

Oral Cancer

Lip and Oral Cavity Cancer

Herbal and Botanical

All Drugs and Chemicals

Raspberry

Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks.

Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.

Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.

Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.

Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.

Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.

Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients

Fast release BRB confection

Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients

Intermed release BRB confection

Prolonged release BRB confection includes lyophilized black raspberry powder, corn syrup, corn starch, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients.

Prolong release BRB confection

Yael Vodovotz, Ph.D.

This clinical trial studies black raspberry confection in preventing oral cancer in healthy volunteers. Black raspberry contains ingredients that may prevent or slow the growth of certain cancers.

PRIMARY OBJECTIVES:

I. To select an optimal black raspberry confection based on altered gene expression and chemical profiles in healthy individuals exposed to 3 black raspberry-based amorphous functional confections with modulated bioactive release rate at two doses (4 g and 8 g).

OUTLINE: Participants are randomized to 1 of 6 arms after 2 weeks.

ARM I: Participants receive black raspberry (BRB) confection 1 fast release orally (PO) 4-6 hours apart thrice daily (TID) for 2 weeks.

ARM II: Participants receive BRB confection 2 fast release PO 4-6 hours apart TID for 2 weeks.

ARM III: Participants receive BRB confection 1 intermediate release PO 4-6 hours apart TID for 2 weeks.

ARM IV: Participants receive BRB confection 2 intermediate release PO 4-6 hours apart TID for 2 weeks.

ARM V: Participants receive BRB confection 1 prolonged release PO 4-6 hours apart TID for 2 weeks.

ARM VI: Participants receive BRB confection 2 prolonged release PO 4-6 hours apart TID for 2 weeks.

Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

Phytochemical Release Rate From Black Raspberry Confections Alters Gene Expression and Chemical Profiles Relevant to Inhibition of Oral Carcinogenesis

Compliance and safety of the confections will be evaluated using dietary and sensory questionnaires. The analysis of variance (ANOVA) style model accounting for the random effect of the individual subject and the fixed effect of the dissolution (amorphous confection form) group will be used to examine the effect of attribute data, gender, and age using a 9-point hedonic scale. The significant differences between means of the different groups will be examined using the Ryan-Einot-Gabriel-Welsch (REGW) multiple comparisons test.

To select an optimal delivery vehicle \& dose, a combination that results in any of 10 subjects having an adverse event will be eliminated in the 1st stage. In the 2nd and 3rd stages ANOVA style models accounting for the random effect of individual subject and the fixed effect of dose \& release rate will be used to examine phytonutrient metabolite \& gene expression. Using the multiple comparisons with the best procedure, any combination will be eliminated that is significantly worse than the best combination for a global index of bioavailability (stage 2) and gene expression effects (stage 3).

Ohio State University Comprehensive Cancer Center

Principal Investigator

Ear, Nose, and Throat Diseases

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Carcinoma, Verrucous

Oropharyngeal Neoplasms

Tongue Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Diseases

Tongue Diseases

Tongue Cancer

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

Former oral cancer patients receive lozenges containing freeze-dried black raspberry (BRB) powder. They will take the lozenges four times each day (QID) by mouth (PO) for up to 6 months.

Patients will be asked to complete a baseline survey documenting any family history of cancer, tobacco, alcohol, and mouthwash use, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) Survey, and a Brief Fatigue Inventory (BFI) Survey.

They will receive a trial-specific logbook to record their usages.

Intervention: Black Raspberry (BRB) Lozenge Intervention: Survey Administration Intervention: Laboratory Biomarker Analysis

Former oral cancer patients will not receive lozenges containing freeze-dried black raspberry (BRB) powder.

Patients will be asked to complete a baseline survey documenting any family history of cancer, tobacco, alcohol, and mouthwash use, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) Survey, and a Brief Fatigue Inventory (BFI) Survey.

They will receive a trial-specific logbook to record their usages.

Intervention: Survey Administration Intervention: Laboratory Biomarker Analysis

ARM I: Patients will be instructed to begin BRB administration and continue daily for up to 6 months.

BRB Lozenge

Patients will complete a baseline survey documenting any family history of cancer. Patients will then provide a history of tobacco, alcohol and mouthwash use, complete the Head and Neck Cancer Inventory Survey (HNCI), the Insomnia Severity Index (ISI) Survey, and the Brief Fatigue Inventory (BFI) Survey. Patients will receive a trial-specific logbook to record their usages.

Survey Administration

Patients will provide blood, urine, saliva, and cheek scrape samples. These biological samples will be evaluated for the presence of BRB components (as a measure of compliance) and assessed for BRB-responsive gene expression, respectively.

Laboratory Biomarker Analysis

pharmacological study

Amit Agrawal, MD

This pilot clinical trial studies freeze-dried black raspberries (BRB) in preventing oral cancer recurrence in high at-risk Appalachian patients previously treated with surgery for oral cancer. Chemoprevention is the use of drugs natural products to keep cancer from developing, progressing, or recurring. Giving freeze-dried black raspberries may prevent oral cancer from forming or returning in oral cancer survivors.

PRIMARY OBJECTIVES:

I. To conduct an initial early phase clinical study utilizing a high ar-risk and underserved Appalachian population who are former oral cancer patients to determine the practicability of long-term daily freeze-dried black raspberry (BRB) (BRB lozenge) administration and to gain insights into the potential prevention of recurrent oral cancer by BRBs.

SECONDARY OBJECTIVES:

I. Evaluate numerous parameters (recruitment, tolerability, adherence to study guidelines, collection of biological samples, and demographics) that will be helpful in designing a future definitive, randomized, Phase II or III clinical trial structured to assess the potential effects of long-term BRB administration.

II. Evaluate the temporal modulation of BRB-responsive gene expression that favor oral cancer chemoprevention in high at-at risk normal tissues before and after BRB administration.

III. Assess the temporal modulation of BRB-responsive gene expression and biological levels of fruit components in post-surgical oral cancer patients not exposed to BRBs.

OUTLINE: Patients are assigned to 1 of 2 treatment arms.

ARM I: Patients receive freeze-dried black raspberry lozenges orally (PO) 4 times daily (QID) for up to 6 months.

ARM II: Patients do not receive freeze-dried black raspberries lozenges.

After completion of study treatment, patients in Arm I are followed for up to 5 years and patients in Arm II are followed for up to 1 year for oral cancer recurrence.

Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors

Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer

Two side tests and confidence intervals will be constructed using the exact binomial formulation.

Adherence rates for subjects on LBR will be evaluated using 95% confidence intervals based on the exact binomial formulation (margins of error will be approximately 8% based on an expected compliance rate near 75% of subjects).

Reverse transcriptase polymerase chain reaction (RT-PCR) data will be analyzed on the log scale using repeated measures analysis of variance (ANOVA) models and the Bonferroni correction to adjust for the multiple inference problem

Reverse transcriptase polymerase chain reaction (RT-PCR) data will be analyzed on the log scale using repeated measures analysis of variance (ANOVA) models and the Bonferroni correction to adjust for the multiple inference problem.

RT-PCR data will be analyzed on the log scale using repeated measures ANOVA models and the Bonferroni correction to adjust for the multiple inference problem. Genes that show changes with berries will also be compared with to a control group of 30 subjects who refuse LBR treatment but agree to be included in biomarker studies and for whom baseline alcohol and smoking history will be available

Oral Squamous Cell Carcinoma

Day 1 of BRB will be determined based upon the anticipated surgery day. Subjects will be instructed to consume a total dose of 5 Gm/day (orally) by taking one BRB five times a day: one upon waking in the morning, one in the morning, one at noon, one in the evening, and one at bedtime. BRB should not be given during meals and drinking. The subject should avoid eating for about 30 minutes before and after taking a BRB.

Each BRB contains 1 gram of black raspberry powder equal to roughly 6 black raspberries.

Black Raspberry

Mitchell Machtay, MD

Xin Liu, MD, Ph.D

The purpose of this phase 0 Window of Opportunity study is to have subjects with Head and Neck Squamous Cell Carcinoma (HNSCC) receive same dosage of Black Raspberry Extract between their cancer diagnosis and standard treatment (surgery). Tumor biopsies and research blood before and after the investigational treatment (Black Raspberry Extract lozenges) are collected for translational research. The investigational treatment is kept short to avoid delaying standard treatment.

The global incidence of head and neck squamous cell carcinoma (HNSCC) currently rests at roughly 630,000 cases per year, with approximately half of all cases resulting in death. In the United States alone, an estimated 3% of all cancers diagnosed yearly are comprised of oral cavity and pharynx cancers, accounting for 63,000 cases per year and 13,000 related deaths. The high rates of incidence and prevalence in HNSCC are largely due to a lack of effective long term treatment. Treating cancer, including HNSCC at late stages even with recent advances in targeted therapies continues to be a major challenge and thus mechanistically-based effective strategies to manage and control this disease are urgently needed. Epidermal Growth Factor Receptor (EGFR) is over expressed in about 90% of HNSCC; it is associated with a poor prognosis and it is an attractive therapeutic target for HNSCC.

Many cultures throughout history and across the world have used plants and herbs to treat medical problems and a percentage of modern medicines have been extracted from plants.Black Raspberries (BRB), also referred to as "blackcaps", are an entirely natural resource available over-the-counter for purchase. BRB contains high concentrations of anthocyanins which serve as antioxidants that help prevent free radical damage in the body. Rich in levels of Vitamin A and calcium, these berries have not shown any adverse reaction upon consumption nor pose any threat when taken in conjunction with other medications. Researchers confirmed that 14-day before surgical administration of BRB troches significantly reduced the gene expression of many biomarkers that are consistently overexpressed in Oral Squamous Cell Carcinoma (OSCC).

The investigator proposes the possibility of introducing BRB that may improve biomarkers such as tumor suppressor p120ctn and reduce resistance modulated by EGFR and its pathways, and anticipates that the results of this clinical trial will not only demonstrate the highly safe and feasible nature of adding BRB to standard therapy, but that there will be considerable, favorable changes in the molecular biology of these patients' cancers and their immune status.

All subjects will be a part of the same treatment group and receive the same dosage.

A Window of Opportunity Study of Black Raspberry for Patients With HNSCC

A Window of Opportunity Study of Black Raspberry for Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

H-score is a quantitative variable and can be obtained from analyzing the tissue samples

All the adverse events will be summarized via frequency tables by type, grade, severity, and relationship to the study medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers	NCT01961869	Healthy Volunte...	Fast release BR... Intermed releas... Prolong release...	18 Years - 65 Years	Ohio State University Comprehensive Cancer Center
Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers	NCT01961869	Healthy Volunte...	Fast release BR... Intermed releas... Prolong release...	18 Years - 65 Years	Ohio State University Comprehensive Cancer Center
Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors	NCT01504932	Stage I Squamou... Stage I Squamou... Stage I Verruco... Stage II Squamo... Stage II Squamo... Stage II Verruc... Stage III Squam... Stage III Squam... Stage III Verru... Stage IVA Squam... Stage IVA Squam... Stage IVA Verru... Stage IVB Squam... Stage IVB Squam... Stage IVB Verru... Stage IVC Squam... Stage IVC Squam... Stage IVC Verru... Tongue Cancer	BRB Lozenge Survey Administ... Laboratory Biom... pharmacological...	21 Years -	Ohio State University Comprehensive Cancer Center
Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers	NCT01961869	Healthy Volunte...	Fast release BR... Intermed releas... Prolong release...	18 Years - 65 Years	Ohio State University Comprehensive Cancer Center
A Window of Opportunity Study of Black Raspberry for Patients With HNSCC	NCT06086925	Squamous Cell C...	Black Raspberry	18 Years -	Milton S. Hershey Medical Center

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