Natural Supplements and a Special Diet in Eliminating Cancer-impacting Hormones From Sources Outside the Body in Patients With Early-Stage or Remission Prostate Cancer, Breast Cancer, or Uterine Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
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: June 2, 2014
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: 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 supplements and a special diet work, extemporaneous and environmental (man-made) hormones, hormone impacting compounds and hormone-mimicking compounds that are made outside the body, found in manufactured products or in-taken to the body of cancer patients through life-style, environmental or consumption products. Patients with early-stage or remission stage prostate cancer, breast cancer, or uterine cancer have a much greater sensitivity to these extemporaneous hormonal or hormonal influencing compounds.


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: April 2015
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: October 2015 (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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910884

Locations
United States, Washington
Brabant Research, Incorporated Not yet recruiting
Spokane Valley, Washington, United States, 99216
Contact: Richard E. Lasker, PhD    509-340-9902    rel@brabantresearch.com   
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: June 2, 2014
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 August 27, 2014