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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Prostate Cancer, Sarcoma

Thank you

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of prostate, breast, or uterine cancer

- Early-stage disease

- Currently waiting to initiate conventional therapy or radiotherapy OR receiving
concurrent conventional chemotherapy or radiation therapy

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Prior or concurrent chemotherapy or hormonal therapy for cancer allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Sequestration and elimination of exogenous estrogens from the body using multiple naturally-occurring micro-trace element compounds

Outcome Description:

lowering body estrogens as related to hormone driven cancer

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Richard E. Lasker, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brabant Research

Authority:

United States: Institutional Review Board

Study ID:

CDR0000643461

NCT ID:

NCT00910884

Start Date:

November 2013

Completion Date:

July 2014

Related Keywords:

  • Breast Cancer
  • Prostate Cancer
  • Sarcoma
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • male breast cancer
  • stage I uterine sarcoma
  • stage II uterine sarcoma
  • stage I prostate cancer
  • stage II prostate cancer
  • Breast Neoplasms
  • Prostatic Neoplasms
  • Sarcoma

Name

Location

Brabant Research, IncorporatedMonroe, Washington  98272