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This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Fasting | Experimental | Patients will undergo 16h periods of fasting everyday. Optionally, patients will be offered to undergo a plant-based diet consisting of 20% plant based protein, 50% carbohydrates, and 30% fat for the duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Fasting | Other | Dietary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy | 3 years |
| Drop-out rate | Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging. | Clinical efficacy of the combination of intermittent fasting with or without a plant-enriched diet plus androgen deprivation therapy | 3 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Pili, MD | Contact | 716-881-8918 | rpili@buffalo.edu | |
| Kyle Pasquariello | Contact | 716-529-6470 | KPasquariello@gppconline.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo/Great Lakes Cancer Center | Recruiting | Buffalo | New York | 14203 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Longitudinal
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Safety, tolerability and reduction of common toxicities of the combination of intermittent fasting and the option of a plant-enriched diet intervention as compared to historical data. |
| 3 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |