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Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer

NCT02710721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-12-13

No results posted yet for this study

Summary

The aim of this trial is a first evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with CRPC or hormone-sensitive prostate cancer with high metastatic load (1≥ visceral and ≥4 osseous metastases) in respect to quality of life, reduction of side effects and possible reduction in tumor progression.

Conditions

  • Fasting
  • Prostatic Neoplasms

Interventions

OTHER

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.

OTHER

Control

Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Andreas Michalsen, Prof. Dr. · Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften

  • Kurt Miller, Prof. Dr. · Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie

  • Ursula Steiner, Dr. · Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
89 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-07-31
Completion
2022-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02710721 on ClinicalTrials.gov