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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA280081-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians.
This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting Mimicking Diet | Experimental | Intermittent fasting using a fasting mimicking diet |
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| Standard Anti-Cancer Diet | Placebo Comparator | Standard Anti-Cancer Diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting Mimicking Diet (FMD) | Behavioral | Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Response to cancer treatment | Will be measured by the proportion of patients who achieved PSA nadir ≤0.2 ng/dL at any time point within the 6-month study and absolute PSA nadir. | 6 Month visit |
| Measure | Description | Time Frame |
|---|---|---|
| Castration resistance 1 | will be measured by Testosterone (ng/dl) | 6 Month visit |
| Castration resistance 2 | will be measured by PSA levels (ng/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Recruitment Navigator | Contact | 3104232133 | GroupCancerTrialInformation@cshs.org | |
| Stephen Freedland, MD | Contact | 310-423-3497 | Stephen.Freedland@cshs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beckman Research Institute of the City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| Standard Anti-Cancer Diet | Behavioral | Will receive standard of care diet and exercise recommendations from the study dietitian. The diet advice will be consistent with the American Cancer Society for cancer survivors and exercise recommendation of a goal of 150 minutes/week of cardiovascular exercise and weight resistance training at least twice a week. |
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| 6 Month visit |
| Metabolic Toxicity 1 | Will be measured by the changes in HbA1c | Change from Baseline to 6 Month visit |
| Metabolic Toxicity 2 | Will be measured by the changes in waist circumference | Change from Baseline to 6 Month visit |
| Metabolic Toxicity 3 | Will be measured by the changes in fat mass (assessed via bioelectrical expedience) | Change from Baseline to 6 Month visit |
| Metabolic Toxicity 4 | Will be measured by the changes in body weight | Change from Baseline to 6 Month visit |
| Self-reported overall well-being | will be measured in changes in the scores calculated from the Medical Outcomes Study Short Form Health Survey (SF-12) questionnaire. Scores can range from 12-56 with a higher score indicating a better outcome. | Change from Baseline to 6 Month visit |
| Self-reported energy levels | will be measured in changes in the scores calculated from the Godin leisure-time physical activity questionnaire. Scores can range from 0 and above, with a higher score indicating a better physical activity outcome. | Change from Baseline to 6 Month visit |
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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