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

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitchell Machtay

Criteria

Inclusion Criteria:

1. Males or females ≥ 18 years of age

2. 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

3. The cancer may be HPV+ or HPV-, as defined by biomarker testing such as p16 immunohistochemistry.

4. ECOG performance status 0-2

5. Confirmation of adequate tissue from previous biopsy for immunohistochemistry analysis

6. 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

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