NCT02710721

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

4.3 years

First QC Date

February 9, 2016

Last Update Submit

December 12, 2022

Conditions

FastingProstatic Neoplasms

Keywords

FastingProstatic NeoplasmsComplementary TherapiesUrology

Outcome Measures

Primary Outcomes (1)

  • FACT-P/-Taxane/-An sum score

    summarized change of FACT score from baseline to day 8 after each chemotherapy

    Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)

Secondary Outcomes (2)

  • FACT-P/-Taxane/-An sum score

    Assessment day 0 (baseline) and 3 and 6 months after day 0

  • HADS

    Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16) and after 3 and 6 months after study day 0

Other Outcomes (2)

  • Differential blood count

    Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16) and after 3 and 6 months after study day 0

  • Intensity of chemotherapy- related side effects

    Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)

Study Arms (2)

Fasting

EXPERIMENTAL

60h-modified fasting (36h before and 24h after chemotherapy)

Other: Fasting

Control

ACTIVE COMPARATOR

mediterranean diet

Other: Control

Interventions

FastingOTHER

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.

Fasting
ControlOTHER

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

Control

Eligibility Criteria

Age25 Years - 89 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of CRPC or hormone-sensitive prostate cancer with high metastatic load
  • Cancer is treated to guidelines conventionally with chemotherapy or with a combination of hormone therapy and chemotherapy.

You may not qualify if:

  • Underweight (BMI \<20 kg/m2) or actual weight decrease \>2 kg or \>5 kg in the last 1 or 3 months.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie

Berlin, 12200, Germany

Location

MeSH Terms

Conditions

FastingProstatic Neoplasms

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Andreas Michalsen, Prof. Dr.

    Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften

    PRINCIPAL INVESTIGATOR

  • Kurt Miller, Prof. Dr.

    Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie

    PRINCIPAL INVESTIGATOR

  • Ursula Steiner, Dr.

    Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 9, 2016

First Posted

March 17, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2020

Study Completion

December 1, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations

DE(1)