Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was not initiated due to funding constraints and will not proceed in its current design.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Oral Cavity or Oropharynx | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Black Raspberry | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BRB treatment
- description
- 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.
- interventionNames
- Drug: Black Raspberry
Primary outcomes (1)
- measure
- H-score complied through tumor analysis
- timeFrame
- From the start of the BRB through surgery, the average duration ranges from 16 to 30 days
- description
- H-score is a quantitative variable and can be obtained from analyzing the tissue samples
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \-
References
Publications (0)
Data not yet available