Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-relat… (NCT03268993) | Clinical Trial Compass
CompletedNot Applicable
Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer
United States6 participantsStarted 2018-07-27
Plain-language 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 study, participants who have been curatively treatment for head and neck cancer, will take Avmacol twice a day for 3 months.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Change in NRF2 target gene expression
Timeframe: From baseline throughout treatment period, up to 4 months
✕. 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).