Status:
WITHDRAWN
A Window of Opportunity Study of Black Raspberry for Patients With HNSCC
Lead Sponsor:
Mitchell Machtay
Conditions:
Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 diagn...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06086925
Start Date
June 1 2025
End Date
December 1 2027
Last Update
July 11 2025
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