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This is a prospective observational cohort study of patients with prostate cancer who have a metabolic syndrome. The study aims to evaluate the role of intermittent fasting (fasting mimicking diet) in these patients. The primary end point is metabolic health and the secondary endpoint is quality of life.
Cancer is a complex set of conditions which collectively comprise the second biggest cause of death in the western world. In addition, these diseases, along with their various treatments, are associated with significant illness, as well as a host of debilitating symptoms. Two very common problems are cancer fatigue, as well as metabolic changes which can cause much suffering in and of themselves. Patients with advanced cancers, as well as many patients undergoing surgery, radiation therapy as well as chemotherapy all complain of fatigue, to a greater or lesser extent. Many gain or lose weight, and develop associated metabolic changes in uninvolved body systems, which can cause a significant health burden on the patients, as well as the healthcare system as a whole.
Little is known about the mechanisms which underlie these symptoms. Various biologic processes have been implicated including inflammation and other changes in body metabolism. There is urgent need to better understand these processes, which cause so much suffering in cancer patients, so as to potentially develop more effective solutions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting mimicking diet | Other | 3 cycles of programmed nutrition using a fasting mimicking diet (Chemolieve (R)), each cycle consisting of 4 days. Pre and post nutritional cycles, clinical and metabolic assessments are taken, as per protocol. Allowing for a 3 month "washout" time, the 'post' assessment is planned approximately 6 months from the initial (pre) assessment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline Weight (in kilograms) at 6 months | Metabolic health parameter | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months |
| Change in Baseline Blood Pressure (in millimeters of Mercury) at 6 months | Metabolic health parameter | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months |
| Change in Baseline Waist Circumference (in centimeters) at 6 months | Metabolic health parameter | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months |
| Change in Baseline Triglycerides Level (in millimoles per litre) at 6 months | Clinical lab results | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months |
| Change in Baseline Total, LDL, and HDL Cholesterol (in millimoles per litre) at 6 months | Clinical lab results | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline EQ5D5L Health Questionnaire Score at 6 months | Structured Quality of Life Measure - Patients' self report of mobility, self-care, usual activities, pain/discomfort, anxiety/depression -
|
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Inclusion Criteria:
Exclusion Criteria:
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A cohort of 40 men with biopsy-proven prostate cancer having features of a metabolic syndrome, receiving standard treatment options for their disease.
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| Name | Affiliation | Role |
|---|---|---|
| Frank Sullivan, MSc | Galway Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galway Clinic | Galway | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31728501 | Result | Brandhorst S, Longo VD. Protein Quantity and Source, Fasting-Mimicking Diets, and Longevity. Adv Nutr. 2019 Nov 1;10(Suppl_4):S340-S350. doi: 10.1093/advances/nmz079. | |
| 20395504 | Result | Fontana L, Partridge L, Longo VD. Extending healthy life span--from yeast to humans. Science. 2010 Apr 16;328(5976):321-6. doi: 10.1126/science.1172539. |
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None planned
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D024821 | Metabolic Syndrome |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months |
| Change in Baseline EQ5D5L Vertical Visual Analogue Scale Score at 6 months | Structured Quality of Life Measure - Patients' self report on how good/bad their health is TODAY -
| Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months |
| Change in Baseline Chalder Fatigue Index Score at 6 months | Structured Tiredness/Fatigue Measures on Likert Scale - Patients' self report of fatigue symptoms - 0: Less than usual
| Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months |
| 25153840 | Result | Mirzaei H, Suarez JA, Longo VD. Protein and amino acid restriction, aging and disease: from yeast to humans. Trends Endocrinol Metab. 2014 Nov;25(11):558-66. doi: 10.1016/j.tem.2014.07.002. Epub 2014 Aug 19. |
| 35314788 | Derived | Fay-Watt V, O'Connor S, Roshan D, Romeo AC, Longo VD, Sullivan FJ. The impact of a fasting mimicking diet on the metabolic health of a prospective cohort of patients with prostate cancer: a pilot implementation study. Prostate Cancer Prostatic Dis. 2023 Jun;26(2):317-322. doi: 10.1038/s41391-022-00528-3. Epub 2022 Mar 21. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |