Broccoli Sprout Extract in Preventing Recurrence in Patients with Tobacco-Related Head and Neck Squamous Cell Cancer

Inclusion Criteria

• 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); NOTE: the presence of a measurable OPL at baseline is not required
• Primary site may include oral cavity, pharynx, or larynx; oropharynx primaries must be human papilloma virus (HPV) (-) as defined by routine p16 immunohistochemistry (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; the tobacco use assessment form must be completed following consent, to assure eligibility; 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 Criteria

• Patient has a history of another malignancy within 2 years prior to starting study treatment, except for stage I-II malignancy that has been treated curatively with no clinical evidence of disease, 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 anti-coagulation 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. (Note, physiologic replacement doses of glucocorticoid or mineralocorticoid are acceptable, e.g. prednisone 5-10 mg/day; fludrocortisone 0.1-0.2 mg/day)
• History of severe food intolerance to broccoli