Trial Information

Gene Expression Control Using Micro-Trace Element Compounds During C.A.M. and Conventional Cancer Protocols

OBJECTIVES:

- To utilize multiple naturally-occurring micro-trace element compounds to sequester
exogenous estrogens from multiple sources, including environmental and metabolic
sources, and eliminate them from the body prior to influencing prostate, breast, and
uterine cancer pathways.

- To utilize specific naturally-occurring flavonoids to suppress
proliferation-stimulating activities induced by normal metabolism and environmental
estrogen, estrogen-mimicking, and testosterone compounds.

- To utilize DPPH radical-scavenging activity to reduce secondary bonding of TMPRSS2-ERG
fusing and negative-bonded environmental estrogen.

- To utilize a full diet of specifically grown inclusion produce to maintain normal
metabolic function.

OUTLINE: Patients are randomized to 1 of 2 arms.

- Arm I: Patients receive oral natural supplements comprising indole-3-carbinol, perillyl
alcohol, glucuronic acid, and flavonoids daily for 12 months. Patients also consume
whole foods comprising indole-3-carbinol and a diet that eliminates exogenous growth
hormones.

- Arm II: Patients do not receive natural supplements or consume whole foods or a special
diet.

Levels of compounds of interest are measured by inductively-coupled plasma mass
spectrometry, high performance liquid chromatography, gas chromatography, and
matrix-assisted laser desorption/ionization time of flight mass spectrometry.

After completion of study therapy, patients are followed periodically for 6 months.