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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Intervention / Treatment
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* Drug: Black Raspberry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females ≥ 18 years of age Histology and/or pathology of untreated squamous cell carcinoma (SCC) of the oral cavity or oropharynx, greater than stage 0 and planned for definitive surgery The cancer may be HPV+ or HPV-, as defined by biomarker testing such as p16 immunohistochemistry. ECOG performance status 0-2 Confirmation of adequate tissue from previous biopsy for immunohistochemistry analysis A surgery date must be anticipated to occur within 16 to 30 days after the first dose of BRB Exclusion Criteria: 1. Inability to provide informed consent 2. Pregnancy or breast feeding 3. Chemotherapy with the exception of low dose chemo being used for non-cancer treatments (eg. methotrexate for rheumatoid arthritis etc.) 4. Known hypersensitivity to BRB -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: All subjects will be a part of the same treatment group and receive the same dosage.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRB treatment<br>All Subjects will receive a dosage of 5 Gm freeze-dried slow-release BRB per day. Subjects will be instructed to consume 5 Gm/day, one BRB before or after each meal, one upon waking, and one prior to bed, for 14 days and a maximum of 28 days. BRB should not be given during meals and drinking. The subject will place the BRB under tongue or in the cheek cavity, between cheek and gums, until the BRB dissolves completely (approximately 15-30 minutes). Subject will be instructed not to chew the BRB. | Drug: Black Raspberry<br>* Each BRB contains 1 gram of black raspberry powder equal to roughly 6 black raspberries.<br>* Other names: BRB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H-score complied through tumor analysis | H-score is a quantitative variable and can be obtained from analyzing the tissue samples | From the start of the BRB through surgery, the average duration ranges from 16 to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety data collection | All the adverse events will be summarized via frequency tables by type, grade, severity, and relationship to the study medicine | 7-10 days after BRB treatment to 21- 42 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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black raspberry, head and neck squamous cell carcinoma