HNSCCEarly Phase 1NCT03182959
Broccoli Sprout Extract in Preventing Recurrence in Patients With Tobacco-Related Head and Neck Squamous Cell Cancer
A Early Phase 1 study testing Avmacol® in people with HNSCC and Head and Neck Cancer, run by University of Arizona at 1 site in United States.
Trial summary
This study is being done to see whether Avmacol®, a dietary supplement made from broccoli sprout and seed extract powder, induces changes in inner cheek cells that may be protective against environmental toxins such as tobacco. There are three main goals of the study: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HNSCC, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Avmacol®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2017to 19 Jan 2021
- 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
- Patients must have completed curative-intent therapy (including surgery, radiation, and/or chemotherapy) for a first tobacco-related oral premalignant lesion (OPL) or HNSCC of any stage (eligible lesions include high grade dysplasia; carcinoma in situ; or stage I-IVa HNSCC).
- Primary site may include oral cavity, pharynx, or larynx. Oropharynx primaries must be human papillomavirus (HPV) negative as defined by routine p16 IHC at the local site.
- Patients may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy).
- Patients may have untreated OPLs (i.e., hyperplasia, dysplasia, carcinoma in situ) at the time of study entry, provided the index OPL or HNSCC was definitively treated.
- Patients must have a Karnofsky Performance Status of 80% or higher or an Eastern Cooperative Oncology Group (ECOG) of 0-1
- Current and former tobacco users are eligible.
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- Able to perform written, informed consent.
- Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 Days prior to the first study intervention.
- WCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.
Who cannot join
- Patient has a history of another malignancy within 2 years prior to starting study treatment, except for excised and cured carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T1-2, N0, M0 differentiated thyroid carcinoma either resected or under active surveillance; superficial bladder cancer; T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection, or status post external beam radiation or brachytherapy with normal PSA since radiation.
- Primary oropharyngeal HNSCC which is HPV (+) as defined by p16 immunohistochemistry.
- Participants with acute intercurrent illness or those who had major surgery within the preceding 4 weeks unless they have fully recovered.
- Participants who have a positive pregnancy test, are pregnant, or breast feeding.
- Patients who are not practicing adequate contraception are ineligible if they are of child bearing potential.
- Patients currently using anti-neoplastic or anti-tumor agents, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy.
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- Chronic anticoagulation with warfarin. Patients on low molecular weight heparin or fondaparinux may be enrolled.
- Use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4
- Chronic use of steroids at immunosuppressive doses.
- History of severe food intolerance to broccoli.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Phase 0 Study Evaluating the Systemic Bioavailability and Pharmacodynamic Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer
This study is being done to see whether Avmacol®, a dietary supplement made from broccoli sprout and seed extract powder, induces changes in inner cheek cells that may be protective against environmental toxins such as tobacco.
There are three main goals of the study:
- To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair damage from environmental toxins;
- to learn how the body metabolizes Avmacol®, by measuring its byproducts in the participant's urine and blood;
- to learn whether the immune system can be stimulated by Avmacol®, by studying the natural killer cells and T cells in the participant's blood.
Read the detailed description
This study hypothesizes that nuclear factor erythroid 2-related factor 2 (NRF2) pathway activation in oral epithelium can be induced by administering Avmacol® to patients curatively treated for a first tobacco-related HNSCC.
The aim of this Phase 0 clinical study is to determine the oral bioavailability of sulforaphane in the commercially available dietary supplement, Avmacol®, and to determine the level of pharmacodynamic upregulation of NRF2 target gene transcripts that occurs in the oral epithelium of patients who have completed curative treatment for tobacco-related HNSCC, including high grade dysplasia, carcinoma in situ, or invasive carcinoma.
- Conditions
- HNSCC, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Tobacco-Related Carcinoma, Carcinoma in Situ, Dysplasia
- Being tested
- Avmacol®
- Keywords
- Nrf2 pathway, Oral mucosa, HNSCC, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Avmacol, Tobacco-related Head and Neck Cancer, broccoli sprout powder, broccoli seed extract powder
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Carcinoma in Situ, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avmacol®Drug
Also called Broccoli Sprout Extract
Avmacol® tablets
| Study group | Role | What they receive |
|---|---|---|
| Lower dose, higher dose | Experimental | During the first cycle, the patient will self-administer Avmacol® (70 μmol/day SF equivalent) starting on the evening of Day 1 of the cycle. Participants will self-administer four tablets of Avmacol® every evening, ideally between 4 pm and 8 pm, through the evening of Day 28. Participants will record the date and time of each Avmacol® administration on the provided diary.
During the second cycle, the patient will self-administer Avmacol® (140 μmol/day SF equivalent) starting on the evening of Day 1 of the cycle. Participants will self-administer eight tablets of Avmacol® every evening, ideally between 4 pm and 8 pm, through the evening of Day 28. Participants will record the date and time of each Avmacol® administration on the provided diary. Receives: Drug: Avmacol® |
| Higher dose, lower dose | Experimental | During the first cycle, the patient will self-administer Avmacol® (140 μmol/day SF equivalent) starting on the evening of Day 1 of the cycle. Participants will self-administer eight tablets of Avmacol® every evening, ideally between 4 pm and 8 pm, through the evening of Day 28. Participants will record the date and time of each Avmacol® administration on the provided diary.
During the second cycle, the patient will self-administer Avmacol® (70 μmol/day SF equivalent) starting on the evening of Day 1 of the cycle. Participants will self-administer four tablets of Avmacol® every evening, ideally between 4 pm and 8 pm, through the evening of Day 28. Participants will record the date and time of each Avmacol® administration on the provided diary. Receives: Drug: Avmacol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether Avmacol® results in acute and/or sustained induction of NRF2 target gene transcripts in the oral mucosa of patients who have been curatively treated for a tobacco-related HNSCC.
Quantitative changes in NRF2 target gene transcripts (i.e. NAD(P)H Quinone Dehydrogenase 1 [NQO1] and GCLC) in buccal cytobrush by quantitative polymerase chain reaction (qPCR) according to a linear mixed model framework.
Measured: 4 months
Secondary outcomes (12)
Determine whether NRF2 target protein expression is upregulated by Avmacol® in the oral mucosa.
Change in NRF2 target proteins in buccal punch biopsies by immunoblotting.
Measured: 4 months
Evaluate for a dose-response relationship between Avmacol® dose and quantitative change in candidate NRF2 pathway biomarkers in oral mucosa.
Acute change in NRF2 target gene transcripts, as compared to baseline, between the two doses of Avmacol®.
Measured: 4 months
Evaluate oral mucosa for quantitative modulation of NRF2-independent biomarkers of sulforaphane (SF) chemopreventive efficacy, as defined in parallel preclinical models.
Change in NRF2-independent proteins by immunoblotting, eg. STAT3, phospho-STAT3 (pSTAT3).
Measured: 4 months
Evaluate biomarkers of Avmacol® activity in PBMCs gene expression
Alterations in Peripheral Blood Mononuclear Cells (PBMC) gene expression patterns
Measured: 4 months
Evaluate biomarkers of Avmacol® activity in PBMCs flow cytometry
Alterations in Peripheral Blood Mononuclear Cells (PBMC) immune cell sub-populations
Measured: 4 months
Evaluate biomarkers of Avmacol® activity in PBMCs functional assays of T cells and NK cells
Alterations in Peripheral Blood Mononuclear Cells (PBMC) Tcell/ Natural Killer (NK) cell function
Measured: 4 months
Evaluate cytokine biomarkers of Avmacol® activity in serum, including CXCL8, Interleukin 8 (IL8).
Change in serum cytokine levels, as determined by multiplexed bead-based cytokine assays.
Measured: 4 months
Measurement of serum albumin-bound SF using isotope dilution mass spectrometry.
Sulforaphane metabolites will be assessed in overnight urine collected following the first dose of each cycle. The steady state concentration of broccoli seed preparations will be characterized by measuring albumin-bound sulforaphane in serum collected on the last day of each cycle. This assay represents an integrated measure of sulforaphane exposure, which will be correlated with biomarker modulation by means of repeated measures analysis of covariance.
Measured: 4 months
Measure urinary metabolites of SF during administration of two doses of Avmacol®.
Measurement of urinary metabolites of SF using isotope dilution mass spectrometry.
Measured: 4 months
Description of safety profile in accordance with NCI CTCAE v.4.
Patients will receive a diary for daily logging of adverse events. This will tabulated by Avmacol dose and type and grade of adverse events. The mean frequency and grade of events will be calculated by dose, and between-dose differences compared by means of mixed effects analysis of covariance.
Measured: 4 months
Description of the proportion of patients with HNSCC primary tumors harboring genomic alteration of NRF2.
Describe the genetic profile of NRF2 within the index HNSCC primary tumor in the target population.
Archived tumor specimens from the index tobacco-related head and neck squamous cell carcinoma will be collected. Tumor specimens analyzed for genomic alterations in NRF2 and related genes. The frequency of genomic alterations will be characterized.
Measured: 4 months
Description of the proportion of patients with HNSCC primary tumors harboring genomic alteration of NRF2 related genes.
Describe the genetic profile of other related genes within the index HNSCC primary tumor in the target population.
Archived tumor specimens from the index tobacco-related head and neck squamous cell carcinoma will be collected. Tumor specimens analyzed for genomic alterations in NRF2 and related genes. The frequency of genomic alterations will be characterized.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start24 Apr 2017
- Primary completion1 Jan 2020
- Study completion19 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to receive either 50 mg glucoraphanin (GR) in Cycle 1 and 100 mg GR in cycle 2, or 100 mg GR in Cycle 1 and 50 mg GR in Cycle 2, but all participants will receive both doses.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julie E. Bauman, MD, MPH, Principal investigator, The University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182959
- Sponsor's protocol ID
- 1612032762
- Other IDs
- 5P50CA097190
- Status last verified
- Jun 2021
- First submitted
- 18 May 2017
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 Study Evaluating the Systemic Bioavailability and Pharmacodynamic Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03182959
- Acronym / sponsor ID
- 1612032762
- Conditions
- HNSCC, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Tobacco-Related Carcinoma, Carcinoma in Situ, Dysplasia
- Keywords
- Nrf2 pathway, Oral mucosa, HNSCC, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Avmacol, Tobacco-related Head and Neck Cancer, broccoli sprout powder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 9 Jun 2017 (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.
This study is being done to see whether Avmacol®, a dietary supplement made from broccoli sprout and seed extract powder, induces changes in inner cheek cells that may be protective against environmental toxins such as tobacco.
There are three main goals of the study:
- To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair damage from environmental toxins;
- to learn how the body metabolizes Avmacol®, by measuring its byproducts in the participant's urine and blood;
- to learn whether the immune system can be stimulated by Avmacol®, by studying the natural killer cells and T cells in the participant's blood.
Detailed description
This study hypothesizes that nuclear factor erythroid 2-related factor 2 (NRF2) pathway activation in oral epithelium can be induced by administering Avmacol® to patients curatively treated for a first tobacco-related HNSCC.
The aim of this Phase 0 clinical study is to determine the oral bioavailability of sulforaphane in the commercially available dietary supplement, Avmacol®, and to determine the level of pharmacodynamic upregulation of NRF2 target gene transcripts that occurs in the oral epithelium of patients who have completed curative treatment for tobacco-related HNSCC, including high grade dysplasia, carcinoma in situ, or invasive carcinoma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive either 50 mg glucoraphanin (GR) in Cycle 1 and 100 mg GR in cycle 2, or 100 mg GR in Cycle 1 and 50 mg GR in Cycle 2, but all participants will receive both doses.
| Arm | Type | Receives |
|---|---|---|
| Lower dose, higher dose | Experimental | Drug: Avmacol®During the first cycle, the patient will self-administer Avmacol® (70 μmol/day SF equivalent) starting on the evening of Day 1 of the cycle. Participants will self-administer four tablets of Avmacol® every evening, ideally between 4 pm and 8 pm, through the evening of Day 28. Participants will record the date and time of each Avmacol® administration on the provided diary. During the second cycle, the patient will self-administer Avmacol® (140 μmol/day SF equivalent) starting on the evening of Day 1 of the cycle. Participants will self-administer eight tablets of Avmacol® every evening, ideally between 4 pm and 8 pm, through the evening of Day 28. Participants will record the date and time of each Avmacol® administration on the provided diary. |
| Higher dose, lower dose | Experimental | Drug: Avmacol®During the first cycle, the patient will self-administer Avmacol® (140 μmol/day SF equivalent) starting on the evening of Day 1 of the cycle. Participants will self-administer eight tablets of Avmacol® every evening, ideally between 4 pm and 8 pm, through the evening of Day 28. Participants will record the date and time of each Avmacol® administration on the provided diary. During the second cycle, the patient will self-administer Avmacol® (70 μmol/day SF equivalent) starting on the evening of Day 1 of the cycle. Participants will self-administer four tablets of Avmacol® every evening, ideally between 4 pm and 8 pm, through the evening of Day 28. Participants will record the date and time of each Avmacol® administration on the provided diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have completed curative-intent therapy (including surgery, radiation, and/or chemotherapy) for a first tobacco-related oral premalignant lesion (OPL) or HNSCC of any stage (eligible lesions include high grade dysplasia; carcinoma in situ; or stage I-IVa HNSCC).
- Primary site may include oral cavity, pharynx, or larynx. Oropharynx primaries must be human papillomavirus (HPV) negative as defined by routine p16 IHC at the local site.
- Patients may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy).
- Patients may have untreated OPLs (i.e., hyperplasia, dysplasia, carcinoma in situ) at the time of study entry, provided the index OPL or HNSCC was definitively treated.
- Patients must have a Karnofsky Performance Status of 80% or higher or an Eastern Cooperative Oncology Group (ECOG) of 0-1
Key exclusion criteria (10 listed)
- Patient has a history of another malignancy within 2 years prior to starting study treatment, except for excised and cured carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T1-2, N0, M0 differentiated thyroid carcinoma either resected or under active surveillance; superficial bladder cancer; T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection, or status post external beam radiation or brachytherapy with normal PSA since radiation.
- Primary oropharyngeal HNSCC which is HPV (+) as defined by p16 immunohistochemistry.
- Participants with acute intercurrent illness or those who had major surgery within the preceding 4 weeks unless they have fully recovered.
- Participants who have a positive pregnancy test, are pregnant, or breast feeding.
- Patients who are not practicing adequate contraception are ineligible if they are of child bearing potential.
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 |
|---|---|---|
| Avmacol®Also: Broccoli Sprout ExtractAvmacol® tablets | Drug | Higher dose, lower dose, Lower dose, higher dose |
Primary outcome
Determine whether Avmacol® results in acute and/or sustained induction of NRF2 target gene transcripts in the oral mucosa of patients who have been curatively treated for a tobacco-related HNSCC.
Time frame: 4 months
Quantitative changes in NRF2 target gene transcripts (i.e. NAD(P)H Quinone Dehydrogenase 1 [NQO1] and GCLC) in buccal cytobrush by quantitative polymerase chain reaction (qPCR) according to a linear mixed model framework.
12 secondary outcomes
Determine whether NRF2 target protein expression is upregulated by Avmacol® in the oral mucosa.
Time frame: 4 months
Evaluate for a dose-response relationship between Avmacol® dose and quantitative change in candidate NRF2 pathway biomarkers in oral mucosa.
Time frame: 4 months
Evaluate oral mucosa for quantitative modulation of NRF2-independent biomarkers of sulforaphane (SF) chemopreventive efficacy, as defined in parallel preclinical models.
Time frame: 4 months
Evaluate biomarkers of Avmacol® activity in PBMCs gene expression
Time frame: 4 months
Evaluate biomarkers of Avmacol® activity in PBMCs flow cytometry
Time frame: 4 months
Evaluate biomarkers of Avmacol® activity in PBMCs functional assays of T cells and NK cells
Time frame: 4 months
Evaluate cytokine biomarkers of Avmacol® activity in serum, including CXCL8, Interleukin 8 (IL8).
Time frame: 4 months
Measurement of serum albumin-bound SF using isotope dilution mass spectrometry.
Time frame: 4 months
Measure urinary metabolites of SF during administration of two doses of Avmacol®.
Time frame: 4 months
Description of safety profile in accordance with NCI CTCAE v.4.
Time frame: 4 months
Description of the proportion of patients with HNSCC primary tumors harboring genomic alteration of NRF2.
Time frame: 4 months
Description of the proportion of patients with HNSCC primary tumors harboring genomic alteration of NRF2 related genes.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Julie E. Bauman, MD, MPH principal investigator
The University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Avmacol® in people with HNSCC and Head and Neck Cancer, run by University of Arizona at 1 site in United States.
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 9 inclusion and 10 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: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine whether Avmacol® results in acute and/or sustained induction of NRF2 target gene transcripts in the oral mucosa of patients who have been curatively treated for a tobacco-related HNSCC. (time frame: 4 months). 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 21 Jun 2021.