Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer
NCT ID: NCT02710721
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2016-04-30
2022-12-31
Brief Summary
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Detailed Description
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Intermittent fasting as a form of caloric restriction has been studied most extensively experimentally in recent years. It showed consistent beneficial effects on relevant inflammatory and oncological pathways. In the field of preclinical oncology research groups have recently focused on intermittent fasting with chemotherapeutic treatment and promising experimental data have been published. In summary, the combination of fasting and chemotherapy was more effective in various cancer animal models than chemotherapy alone.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Fasting
60h-modified fasting (36h before and 24h after chemotherapy)
Fasting
Patients realize a 60h-modified fasting (36h before and 24h after chemotherapy) with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al. Between chemotherapy a Mediterranean diet with nutrition training individually and in small groups by trained nutritionists at the Study Centre will be practiced.
Control
mediterranean diet
Control
Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.
Interventions
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Fasting
Patients realize a 60h-modified fasting (36h before and 24h after chemotherapy) with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al. Between chemotherapy a Mediterranean diet with nutrition training individually and in small groups by trained nutritionists at the Study Centre will be practiced.
Control
Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.
Eligibility Criteria
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Inclusion Criteria
* Cancer is treated to guidelines conventionally with chemotherapy or with a combination of hormone therapy and chemotherapy.
Exclusion Criteria
* Eating disorder
* Dementia
* Psychosis
* Terminal illness with a significant limitation of mobility and overall vitality
* Diabetes mellitus type 1
* Renal insufficiency stage \> 2, GFR \<60mlmin / 1.73 m2
25 Years
89 Years
MALE
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Andreas Michalsen
Prof. Dr.
Principal Investigators
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Andreas Michalsen, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften
Kurt Miller, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
Ursula Steiner, Dr.
Role: PRINCIPAL_INVESTIGATOR
Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
Locations
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Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
Berlin, , Germany
Countries
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Other Identifiers
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ProstateDiet
Identifier Type: -
Identifier Source: org_study_id