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

Squamous Cell Carcinoma of the Oral Cavity or Oropharynx Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06086925
• Other study ID #: PSCI-21-223
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: Milton S. Hershey Medical Center
• Contact: Mitchell Machtay, MD
• Phone: 7175314181
• Email: mmachtay[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Intervention

Drug:
• Black Raspberry
Each BRB contains 1 gram of black raspberry powder equal to roughly 6 black raspberries.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitchell Machtay

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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