Clinical Trials Logo
NCT number NCT03186937
Study type Interventional
Source University of Wisconsin, Madison
Contact Cancer Connect
Phone 800-622-8922
Email cancerconnect@uwcarbone.wisc.edu
Status Not yet recruiting
Phase Phase 2
Start date June 30, 2017
Completion date June 30, 2019

Clinical Trial Summary

Given preliminary data demonstrating that methionine deprivation enhances cell surface expression of TRAIL receptor-2, the objective of this clinical trial is to confirm that methionine restriction enhances its expression in triple negative breast cancer and to establish the feasibility and acceptability of this dietary intervention in humans. This study will also examine the effect of methionine restriction on cancer stem cells and metabolic health.


Clinical Trial Description

Under the supervision of a registered dietitian, subjects 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. Subjects will be instructed in the preparation of Hominex-2 beverages (4-5 per day) to deliver 100% of daily protein requirements (0.8 g/kg/day) and 40-45% of the caloric requirements. The remaining calories will be met with low-methionine foods, including fruits, vegetables, grains (e.g., specified cereal and bread), margarine and cooking oils. Subjects will be provided with a list of foods that are low in methionine. Calories will not be restricted. Subjects will be encouraged to follow their usual level of physical activity and instructed to maintain a daily diet and exercise diary that will be reviewed weekly by the dietitian.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT01472094 - Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
Recruiting NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Phase 1
Active, not recruiting NCT02139358 - Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Not yet recruiting NCT03210311 - Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema Phase 3
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy N/A
Not yet recruiting NCT03252431 - Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy Phase 3
Not yet recruiting NCT02955394 - Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer Phase 2
Recruiting NCT01992432 - Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC) N/A
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Active, not recruiting NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan. N/A
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Recruiting NCT01967823 - T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer Phase 2
Recruiting NCT02125019 - Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer N/A
Recruiting NCT02739425 - The Efficacy of Sentimag in Detection of Sentinel Node Biopsy N/A
Not yet recruiting NCT03200704 - A Study Assessing the Safety and Utility of IC2000 and SPY Fluorescence Imaging Systems in the Identification of Lymph Nodes During Lymphatic Mapping in Subjects With Breast Cancer Phase 3
Not yet recruiting NCT03122444 - Imipramine on Triple Negative Breast Cancer N/A
Not yet recruiting NCT03159598 - Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive N/A
Not yet recruiting NCT02767661 - Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer Phase 3
Not yet recruiting NCT02943265 - Care Coordination for Complex Cancer Survivors in an Integrated Safety Net System N/A