This randomized double blind placebo controlled study will focus on the immune responses of African and Hispanic Americans who have oral cancer because of the disproportionally higher incidence and death rates from the disease in the populations. The study aims to determine whether oral intake of 200 microg/day of sodium selenite, a dose within the safe and adequate daily intake (50-200 microg/day) recommended by the US Food and Nutrition Board, will 1) abrogate depressed or enhance normal level immune functions of patients receiving therapy and 2) whether discontinuation of the dietary regimen will result in decline in immune functions. The long term objective of the study is to establish whether dietary intake of selenium by immunosuppressed cancer patients can result in improved disease-free survival and decreased morbidity. Our previous studies on healthy human volunteers have shown that oral intake of 200 microg/day of sodium selenite results in a significant enhancement of cell mediated immune functions. Subjects will be randomized to the placebo or selenite groups and asked to take one tablet/day for 8 weeks, beginning on the day of their first treatment for the disease, e.g., surgery, radiation, or surgery and radiation. In vitro valuation of immune functions will be performed using 40 ml peripheral blood samples drawn at four designated intervals, and the ability of peripheral blood lymphocytes to respond to stimulation with antigen, mitogen, and to differentiate into tumor cytotoxic lymphocytes will be evaluated. As an in vivo indicator of immune status, the ability to develop a delayed hypersensitivity response to stimulation with a battery of antigens will be evaluated by skin testing. Plasma selenium levels will be monitored. An enhanced immunocompetence during therapy and the post-therapy period may, consequently, result in improved disease-free survival and decreased morbidity.
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Kiremidjian-Schumacher, L; Roy, M; Glickman, R et al. (2000) Selenium and immunocompetence in patients with head and neck cancer. Biol Trace Elem Res 73:97-111 |