Head and Neck Cancer Clinical Trial
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
NCT number | NCT03268993 |
Other study ID # | 18-028 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 27, 2018 |
Est. completion date | July 22, 2019 |
Verified date | April 2023 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout extracts in tablet form, hypothesized to activate protective cellular pathways including detoxication. In this study, participants who have been curatively treatment for head and neck cancer, will take Avmacol twice a day for 3 months.
Status | Completed |
Enrollment | 6 |
Est. completion date | July 22, 2019 |
Est. primary completion date | July 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Participants 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). 2. Primary site may include oral cavity, pharynx, or larynx. Oropharynx primaries must be HPV (-) as defined by routine p16 IHC at the local site. 3. Participants may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy). 4. Participants 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. 5. Participants must be at least 18 years old. 6. Participants must have a Karnofsky Performance Status of 80% or higher or an ECOG of 0-1 (Appendix A). 7. Current and former tobacco users are eligible. The tobacco use assessment form must be completed following consent, to assure eligibility (Appendix B). Patients must have =10 pack-year cumulative tobacco exposure or its equivalent to be eligible. This is defined as follows: 1. Cigarette exposure: =10 pack-years OR 2. Cigar exposure: = 10 cigar-years, where 1 cigar year is defined as having smoked on average = 1 cigar/day for a year OR 3. Chewing tobacco: =10 snuff-years, where 1 snuff year is defined as using on average = 1 pinch (dip) of chewing tobacco/day for a year. 8. Able to perform written, informed consent. 9. Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 Days prior to the first study intervention. 10. 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. Exclusion Criteria: 1. Participants have 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. 2. Primary oropharyngeal HNSCC which is HPV (+) as defined by p16 IHC. 3. Participants with acute intercurrent illness or those who had major surgery within the preceding 4 weeks unless they have fully recovered. 4. Participants who have a positive pregnancy test, are pregnant, or breast feeding. 5. Patients who are not practicing adequate contraception are ineligible if they are of child bearing potential. 6. Patients currently using anti-neoplastic or anti-tumor agents, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy. 7. Chronic anticoagulation with warfarin. Patients on low molecular weight heparin or fondaparinux may be enrolled. 8. Use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4 (Appendix C). 9. Chronic use of steroids at immunosuppressive doses. (Note, physiologic replacement doses of glucocorticoid or mineralocorticoid are acceptable, eg. prednisone 5-10 mg/day; fludrocortisone 0.1-0.2 mg/day.) 10. History of severe food intolerance to broccoli. |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Eye Center - Eye and Ear Institute | Pittsburgh | Pennsylvania |
United States | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Cancer Institute (NCI), University of Arizona |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in NRF2 target gene expression | Quantitative changes in NRF2 target gene transcripts expression (i.e. NQO1 and GCLC) in oral mucosa (buccal cytobrush) by quantitative polymerase chain reaction (qPCR) according to a linear mixed model framework. | From baseline throughout treatment period, up to 4 months | |
Secondary | Change in NRF2 target proteins | Changes in NRF2 target proteins in buccal punch biopsies by immunoblotting. | From baseline throughout treatment period, up to 4 months | |
Secondary | Change in NRF2 target gene transcripts | Change in NRF2 target gene transcripts, between the two doses of Avmacol® by immunoblotting. | From baseline throughout treatment period, up to 4 months | |
Secondary | Change in NRF2-independent proteins | Change in NRF2 target gene transcripts, between the two doses of Avmacol® by immunoblotting. | From baseline throughout treatment period, up to 4 months | |
Secondary | Alterations of Avmacol® activity in PBMCs - NK cells | Changes in Peripheral Blood Mononuclear Cells (PBMC) gene expression and flow cytometry patterns in NK cells. | From baseline throughout treatment period, up to 4 months | |
Secondary | Alterations of Avmacol® activity in PBMCs - T cells | Changes in Peripheral Blood Mononuclear Cells (PBMC) gene expression and flow cytometry patterns in T cells. | From baseline throughout treatment period, up to 4 months | |
Secondary | Change in serum cytokine levels | Change in serum cytokine levels, as determined by multiplexed bead-based cytokine assays. | From baseline throughout treatment period, up to 4 months | |
Secondary | Measurement of serum albumin-bound SF | Measurement of urinary metabolites of SF using isotope dilution mass spectrometry. | From baseline throughout treatment period, up to 4 months | |
Secondary | 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 | Throughout treatment period, up to 4 months | |
Secondary | Proportion of patients primary tumors harboring genomic alteration of NRF2 related genes | Genomic alterations in primary tumors will be characterized and the proportion determined by number of patients with NRF2 related genes per the total number of patients studied. | At baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |