Breast Cancer Clinical Trial
Official title:
Stage IV Breast Cancer Gene Expression Control Using Micro-Trace and Plant Extracted Natural G.R.A.S. (Generally Accepted As Safe), Compounds in Adjunct Therapy Alongside Conventional Cancer Protocols
RATIONALE: Plant extracted natural compounds, in an adjunct therapy position, slow the growth
and reproduction of Stage IV Breast Cancer tumor cells. May help eradicate different types of
cancers.
PURPOSE: The purpose of this randomized Phase I trial is to first IDENTIFY, through
laboratory analysis and validating cellular biochemical pathways, and HELP CONTROL, using
natural plant extracted compounds, G.R.A.S. (Generally Accepted As Safe), compounds, the
reproduction, growth progress and metastasis of Stage IV Breast Cancer cells. The therapy
position is adjunct to conventional therapies and in "one-off" trials have been excitingly
effective for long-term survival. Novel use of bioactive GRAS compounds to augment and
enhance conventional cancer therapies and as stand-alone parallel therapies.
OBJECTIVES:
To utilize multiple naturally-occurring bioalkaloids, bioactive "compounds of interest" from
multiple sources, to influence prostate, breast, and uterine cancer pathways in cancer
patients and cancer patients in remission. Other cancer types may be applicable.
To utilize specific naturally-occurring bioalkaloids and bioactive "compounds of interest" to
suppress cancer proliferation-stimulation/growth activities induced by normal cancer
metabolism including environmental estrogen impact, estrogen-mimicking compounds,
estrogen-influencing and testosterone-type compounds.
To utilize DNA interaction with proliferating cancer cells via intercalation, which has a
binding impact activity that then impairs DNA polymerase furthering DNA strand breakage and
complete apoptosis. In addition, these bioactive compounds through intercalation, prevent
cancer-cell DNA strand breakage from re-connection and repair, (limitlessness) while
depleting nuclear topoisomerase, the enzyme also targeted by a number of conventional
chemotherapy routes. Finally; a number of the bioalkaloids binds to cancer telomeres capping
them at specific number or reducing them to "one and done."
Natural GRAS compounds, in previous studies that background this research, reduced secondary
bonding of TMPRSS2-ERG fusing affecting testosterone & estrogen hormone influence in cell
proliferation. Variant mRNAs of, for example, the TMPRSS2-ERG fusing pathway were affected
whereas normalized mRNAs in all other cells were not, a mechanism and chemistry not readily
understood.
To utilize natural extracted plant compounds as a means to influence DIABLO (direct inhibitor
of apoptosis binding protein with low isoelectric point) by downregulating over 350 genes
which influence extracellular matrix (ECM) receptor interaction, and complement coagulation
cascades were upregulated.
To utilize applications of, or ingestion of, specifically grown plant species/subspecies,
extract the "compounds of action" or "compounds of activity" but maintaining an
"entourage-affect by protecting "multi-compound complex arrangement chemistry" to maintain
normal metabolic functionality of the compounds of interest..
BACKGROUND DATA:
Pharmaceutica has, since the turn of the 1800s to the 1900s, tried to find, extract and/or
synthesize plant & biological compounds that have the highest activity in a given medical
treatment regime. In many cases the object was to get to the heart of the active compound,
discarding non-active compounds,and, in other cases for various reasons including stockholder
satisfaction, to be able to patent the synthesis chemistry and prevent duplication by
competitors.
The one point of this important to this work is that the natural multi-compounds were the
"compounds of action" for centuries and in most cases, in the natural form they were utilized
in pre-20th century medicine, while the action of control was usually much slower, the side
affects were non-existent.
Recent research (sic) now places a more important role of the "multi-compound" and the
"entourage-effect' they have as cancer cells are quick to evolve, like viruses, and where the
pharmaceutica "single compound of action" approach works well when ALL the cancer cells are
eliminated, does not work well when surviving cells evolve to create resistance...a common
outcome to most advanced stage cancers.
The "entourage-effect" using the "multi-compound" natural extracted compounds appears to
negate the evolution/resistance response of cancerous cells by having multiple "chemistries
of action" involved the cancer-control process which then hides/disguises the metabolic
pathway of control from the surviving cancer cells.
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 and
monitored for a second 6 months period.
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