Status:
COMPLETED
Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Cancer Institute (NCI)
University of Arizona
Conditions:
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma (HNSCC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 stu...
Detailed Description
The broccoli seed preparation, 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-relat...
Eligibility Criteria
Inclusion
- 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).
- Primary site may include oral cavity, pharynx, or larynx. Oropharynx primaries must be HPV (-) as defined by routine p16 IHC at the local site.
- Participants may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy).
- 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.
- Participants must be at least 18 years old.
- Participants must have a Karnofsky Performance Status of 80% or higher or an ECOG of 0-1 (Appendix A).
- 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:
- Cigarette exposure: ≥10 pack-years OR
- Cigar exposure: ≥ 10 cigar-years, where 1 cigar year is defined as having smoked on average ≥ 1 cigar/day for a year OR
- 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.
- 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.
Exclusion
- 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.
- Primary oropharyngeal HNSCC which is HPV (+) as defined by p16 IHC.
- 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.
- 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 (Appendix C).
- 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.)
- History of severe food intolerance to broccoli.
Key Trial Info
Start Date :
July 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03268993
Start Date
July 27 2018
End Date
July 22 2019
Last Update
April 7 2023
Active Locations (2)
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1
UPMC Eye Center - Eye and Ear Institute
Pittsburgh, Pennsylvania, United States, 15213
2
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232