A Window of Opportunity Study of Methionine Deprivation in Triple Negative 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.|
|ClinicalTrials.gov Identifier: NCT03186937|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : April 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Triple Negative Breast Cancer||Dietary Supplement: hominex-2||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Window of Opportunity Study of Methionine Deprivation in Triple Negative Breast Cancer|
|Actual Study Start Date :||August 10, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Participants will receive an individualized dietary prescription that incorporates a methionine-free amino acid-modified medical food (Hominex-2, Abbott Nutrition) supplemented with low-methionine foods. Hominex-2 contains a mixture of L-amino acids but lacks methionine.
Participants will be asked to have an optional non-contrast MRI to assess body composition prior to and at completion of the methionine-restricted (MR) diet. Not completing a scheduled MRI is not considered a protocol deviation.
Participants will be followed for 30 days after surgery or biopsy date. Subjects removed from study for unacceptable adverse events (AEs) will be followed until resolution or stabilization of the AE.
Dietary Supplement: hominex-2
Hominex-2 is a methionine-free amino acid modified medical supplement
- Change in cell surface expression of TRAIL receptor-2 [ Time Frame: Up to 3 weeks ]To determine if methionine restriction can enhance the cell surface expression of TRAIL receptor-2 in triple negative breast cancers.
- Safety and tolerability of methionine measured by number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 3 weeks ]To examine the safety and tolerability of methionine restriction in participants with operable triple-negative breast cancer, measured by the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
- Effect of methionine restriction on cancer stem cell markers CD44 and CD24 [ Time Frame: Up to 3 weeks ]To examine the effect of methionine restriction on the expression of the cancer stem cell markers CD44 and CD24 by immunohistochemistry. Five to ten slides from each time point will be evaluated from baseline and after completion of the methionine restricted diet.
- Change in plasma concentrations [ Time Frame: Up to 3 weeks ]To evaluate plasma concentrations of methionine and methionine metabolites before and after methionine restriction. Blood will be collected after an overnight fast before dietary methionine restriction, weekly during methionine restriction and at the completion of the diet. Plasma concentration will be determined by high-throughput targeted LC-MS (liquid chromatography--mass spectrometry) assay.
- Change in subject weight [ Time Frame: Up to 3 weeks ]To evaluate subject weight before and after dietary methionine restriction. Subjects will be weighed before starting the diet and weekly (every 7 days +/- 1).
- Change in subject BMI [ Time Frame: Up to 3 weeks ]To evaluate subject BMI before and after dietary methionine restriction. Subjects will be weighed before starting the diet and weekly (every 7 days +/- 1).
- Change in subject waist circumference [ Time Frame: Up to 3 weeks ]To evaluate subject BMI, waist circumference and metabolic indices before and after dietary methionine restriction. Waist circumference will be measured before starting the diet and weekly (every 7 days +/- 1) while on the methionine restricted diet.
- Change in subject metabolic indices [ Time Frame: Up to 3 weeks ]To evaluate subject metabolic indices before and after dietary methionine restriction.
- Change in body composition [ Time Frame: Up to 3 weeks ]To evaluate body composition before and after dietary methionine restriction
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): NCT03186937
|Contact: Cancer Connectfirstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Cancer Connect 800-622-8922 email@example.com|
|Principal Investigator: Ruth O'Regan, MD|
|Principal Investigator:||Ruth O'Regan, MD||University of Wisconsin, Madison|