Squamous Cell Carcinoma of the Oral Cavity or OropharynxEarly Phase 1NCT06086925
A Window of Opportunity Study of Black Raspberry for Patients With HNSCC
A Early Phase 1 study testing Black Raspberry in people with Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, run by Mitchell Machtay.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
- What is being tested?
- Black Raspberry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
About this study
Official title: 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.
Read the 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.
- Being tested
- Black Raspberry
- Keywords
- black raspberry, head and neck squamous cell carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black RaspberryDrug
Also called BRB
Each BRB contains 1 gram of black raspberry powder equal to roughly 6 black raspberries.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Black Raspberry |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-score complied through tumor analysis
H-score is a quantitative variable and can be obtained from analyzing the tissue samples
Measured: From the start of the BRB through surgery, the average duration ranges from 16 to 30 days
Secondary outcomes (1)
safety data collection
All the adverse events will be summarized via frequency tables by type, grade, severity, and relationship to the study medicine
Measured: 7-10 days after BRB treatment to 21- 42 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Why it stopped: The study was not initiated due to funding constraints and will not proceed in its current design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Oral Cavity or OropharynxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- All subjects will be a part of the same treatment group and receive the same dosage.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitchell Machtay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mitchell Machtay, Milton S. Hershey Medical Center
- Investigators
- Mitchell Machtay, MD, Principal investigator, Penn State Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086925
- Sponsor's protocol ID
- PSCI-21-223
- Status last verified
- Jul 2024
- First submitted
- 10 Oct 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Window of Opportunity Study of Black Raspberry for Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)
- ClinicalTrials.gov ID
- NCT06086925
- Acronym / sponsor ID
- PSCI-21-223
- Keywords
- black raspberry, head and neck squamous cell carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not initiated due to funding constraints and will not proceed in its current design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mitchell MachtayUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will be a part of the same treatment group and receive the same dosage.
| Arm | Type | Receives |
|---|---|---|
| BRB treatment | Experimental | Drug: Black RaspberryDay 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black RaspberryAlso: BRBEach BRB contains 1 gram of black raspberry powder equal to roughly 6 black raspberries. | Drug | BRB treatment |
Primary outcome
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
1 secondary outcome
safety data collection
Time frame: 7-10 days after BRB treatment to 21- 42 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
Related trials for Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Machtay, MD principal investigator
Penn State Cancer Institute
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Black Raspberry in people with Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, run by Mitchell Machtay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.