Natural Supplements and a Special Diet in Eliminating Growth Hormones Made Outside the Body in Patients With Early-Stage Prostate Cancer, Breast Cancer, or Uterine Cancer

This study is not yet open for participant recruitment.
Verified July 2012 by Brabant Research
Sponsor:
Information provided by (Responsible Party):
Dr. Richard Lasker, Brabant Research
ClinicalTrials.gov Identifier:
NCT00910884
First received: May 29, 2009
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

RATIONALE: Natural supplements and a special diet may help rid the body of estrogen and testosterone and may slow the growth of tumor cells.

PURPOSE: This randomized phase I trial is studying how well natural supplements and a special diet work in eliminating growth hormones that are made outside the body in patients with early-stage prostate cancer, breast cancer, or uterine cancer.


Condition Intervention Phase
Breast Cancer
Prostate Cancer
Sarcoma
Other: laboratory biomarker analysis
Procedure: therapeutic dietary intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Gene Expression Control Using Micro-Trace Element Compounds During C.A.M. and Conventional Cancer Protocols

Resource links provided by NLM:


Further study details as provided by Brabant Research:

Primary Outcome Measures:
  • Sequestration and elimination of exogenous estrogens from the body using multiple naturally-occurring micro-trace element compounds [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    lowering body estrogens as related to hormone driven cancer

  • Suppression of proliferation-stimulating activities using naturally-occurring flavonoids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    suppress cancer cell proliferation

  • Reduction of secondary bonding of TMPRSS2-ERG fusing and negative-bonded environmental estrogen using DPPH radical-scavenging activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Monitor levels

  • Maintenance of normal metabolic function using a full diet of specifically grown inclusion produce [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    metabolic function testing


Estimated Enrollment: 300
Study Start Date: November 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: laboratory biomarker analysis
No supplements are given
Procedure: therapeutic dietary intervention
Given orally daily for 12 months
Placebo Comparator: Arm II
Patients do not receive natural supplements or consume whole foods or a special diet.
Other: laboratory biomarker analysis
No supplements are given

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910884

Locations
United States, Washington
Brabant Research, Incorporated Not yet recruiting
Monroe, Washington, United States, 98272
Contact: Richard E. Lasker, PhD    360-863-0317      
Sponsors and Collaborators
Brabant Research
Investigators
Principal Investigator: Richard E. Lasker, PhD Brabant Research
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Richard Lasker, Director, Brabant Research
ClinicalTrials.gov Identifier: NCT00910884     History of Changes
Other Study ID Numbers: CDR0000643461, BRABANT-00005271
Study First Received: May 29, 2009
Last Updated: July 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brabant Research:
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

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Sarcoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 17, 2014