Natural Supplements Special Diet: Eliminating Cancer-impacting Hormones From Sources Outside the Body in Patients With Early-Stage or Remission Breast Cancer.
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|ClinicalTrials.gov Identifier: NCT00910884|
Recruitment Status : Not yet recruiting
First Posted : June 1, 2009
Last Update Posted : July 21, 2017
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|
|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|
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 givenProcedure: therapeutic dietary intervention
Given orally daily for 12 months
Patients do not receive natural supplements or consume whole foods or a special diet.
Other: laboratory biomarker analysis
No supplements are given
- 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
- Suppression of proliferation-stimulating activities using naturally-occurring flavonoids [ Time Frame: 6 months ]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 ]Monitor levels
- Maintenance of normal metabolic function using a full diet of specifically grown inclusion produce [ Time Frame: 6 months ]metabolic function testing
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 ClinicalTrials.gov 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 firstname.lastname@example.org|
|Principal Investigator:||Richard E. Lasker, PhD||Brabant Research|