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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-1532 | Other Identifier | Institutional Review Board | |
| NCI-2017-01047 | Registry Identifier | NCI CTRP | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison | |
| Protocol Version 11/23/2020 | Other Identifier | UW Madison |
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funding and slow enrollment
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| Name | Class |
|---|---|
| Avon Foundation | OTHER |
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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.
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 (approximately 4-5 per day or per dietician recommendation) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hominex-2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hominex-2 | Dietary Supplement | Hominex-2 is a methionine-free amino acid modified medical supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cell surface expression of TRAIL receptor-2 | To determine if methionine restriction can enhance the cell surface expression of TRAIL receptor-2 in triple negative breast cancers. | Up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of methionine measured by number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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. | Up to 3 weeks |
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Inclusion Criteria:
Participants must have histologically confirmed operable triple negative breast cancer
No prior therapy for current breast cancer
Operable breast cancer. Participants who are planned to undergo neo-adjuvant chemotherapy are eligible as long as they consent to an additional breast biopsy following the dietary intervention immediately prior to starting chemotherapy
ECOG (Eastern Cooperative Oncology Group) performance status ≤1
Ability to understand and the willingness to sign a written informed consent document
Serum creatinine \
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| Name | Affiliation | Role |
|---|---|---|
| Kari Wisinski, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| UW Carbone Cancer Center Homepage | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Effect of methionine restriction on cancer stem cell markers CD44 and CD24 | 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. | Up to 3 weeks |
| Change in plasma concentrations | 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. | Up to 3 weeks |
| Change in subject weight | To evaluate subject weight before and after dietary methionine restriction. Subjects will be weighed before starting the diet and weekly (every 7 days +/- 1). | Up to 3 weeks |
| Change in subject BMI | To evaluate subject BMI before and after dietary methionine restriction. Subjects will be weighed before starting the diet and weekly (every 7 days +/- 1). | Up to 3 weeks |
| Change in subject waist circumference | 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. | Up to 3 weeks |
| Change in subject metabolic indices | To evaluate subject metabolic indices before and after dietary methionine restriction. | Up to 3 weeks |
| Change in body composition | To evaluate body composition before and after dietary methionine restriction | Up to 3 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |