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

January 24, 2024 updated by: Mitchell Machtay

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BRB treatment
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
Each BRB contains 1 gram of black raspberry powder equal to roughly 6 black raspberries.
Other Names:
  • BRB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H-score complied through tumor analysis
Time Frame: From the start of the BRB through surgery, the average duration ranges from 16 to 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety data collection
Time Frame: 7-10 days after BRB treatment to 21- 42 days after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitchell Machtay

Investigators

  • Principal Investigator: Mitchell Machtay, MD, Penn State Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSCI-21-223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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