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

NCT06086925 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: PSCI-21-223
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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

Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Keywords

black raspberry; head and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• safety data collection

  7-10 days after BRB treatment to 21- 42 days after surgery

Study Arms (1)

BRB treatment

EXPERIMENTAL

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.

Drug: Black Raspberry

Interventions

Black Raspberry DRUG

Each BRB contains 1 gram of black raspberry powder equal to roughly 6 black raspberries.

Also known as: BRB

BRB treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Mitchell Machtay: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Mitchell Machtay, MD

  Penn State Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiation Oncology

Model Details: All subjects will be a part of the same treatment group and receive the same dosage.

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2024-07