A Window of Opportunity Study of Black Raspberry for Patients With HNSCC
Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Oral Cavity or Oropharynx focused on measuring black raspberry, head and neck squamous cell carcinoma
Eligibility Criteria
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 -
Sites / Locations
Arms of the Study
Arm 1
Experimental
BRB treatment
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.