An observational study in Prostate Cancer, Metabolic Syndrome and Intermittent Fasting, sponsored by Galway Clinic. Status unknown at 1 site in Ireland. Open to male participants. Per ClinicalTrials.gov, last updated 2020-03-02.
Sponsored by Galway Clinic · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 40 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Galway Clinic as lead sponsor.
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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.
Exclusion Criteria:
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.
Also known as: Programmed cyclic nutrition for 3 monthly cycles (fasting mimicking diet)
Change in Baseline Weight (in kilograms) at 6 months
Metabolic health parameter
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
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 - 1. No problem 2. Slight problems 3. Moderate problems 4. Severe problems 5. Unable to/extreme problems * 5 questions * Minimum score of 0, meaning good quality of life * Maximum score of 25, meaning poor quality of life
Time frame: 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 - * One scale numbered from 0 to 100 * Minimum score of 0, meaning the worst health you can imagine * Maximum score of 100, meaning the best health you can imagine
Time frame: 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 1. No more than usual 2. More than usual 3. Much more than usual * 6 questions * minimum score of 0, meaning no fatigue due to illness * maximum score of 18, meaning chronic fatigue due to illness
Time frame: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Plan to share: No — None planned
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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