Natural Supplements Special Diet: Eliminating Cancer-impacting Hormones From Sources Outside the Body in Patients With Early-Stage or Remission Breast Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00910884
Recruitment Status : Not yet recruiting
First Posted : June 1, 2009
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):
Dr. Richard Lasker, Brabant Research

Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Other: laboratory biomarker analysis Procedure: therapeutic dietary intervention

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Gene Expression Control Using Micro-Trace Element Compounds During C.A.M., Adjunct Therapy and Conventional Cancer Protocols
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : February 2020

Group/Cohort Intervention/treatment
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

Arm II
Patients do not receive natural supplements or consume whole foods or a special diet.
Other: laboratory biomarker analysis
No supplements are given

Primary Outcome Measures :
  1. Sequestration and elimination of exogenous estrogens from the body using multiple naturally-occurring micro-trace element compounds [ Time Frame: 6 months ]
    lowering body estrogens as related to hormone driven cancer

  2. Suppression of proliferation-stimulating activities using naturally-occurring flavonoids [ Time Frame: 6 months ]
    suppress cancer cell proliferation

  3. Reduction of secondary bonding of TMPRSS2-ERG fusing and negative-bonded environmental estrogen using DPPH radical-scavenging activity [ Time Frame: 6 months ]
    Monitor levels

  4. Maintenance of normal metabolic function using a full diet of specifically grown inclusion produce [ Time Frame: 6 months ]
    metabolic function testing

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female in breast cancer remission, any Stage.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer limited to "in-remission only." Any Stage of cancer; wholly limited to "in remission."


  • 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


  • Menopausal status not specified


  • See Disease Characteristics
  • Prior or concurrent chemotherapy or hormonal therapy for cancer allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00910884

United States, Washington
Brabant Research, Incorporated Not yet recruiting
Spokane Valley, Washington, United States, 99216
Contact: Richard E. Lasker, PhD    509-340-9902   
Sponsors and Collaborators
Brabant Research
Principal Investigator: Richard E. Lasker, PhD Brabant Research

Responsible Party: Dr. Richard Lasker, Director, Brabant Research Identifier: NCT00910884     History of Changes
Other Study ID Numbers: CDR0000643461
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Richard Lasker, Brabant Research:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases