Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00010339

Trial Description

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Title

Clinical Study on the Efficacy of Fasting and Nutritional Therapy as a Complementary Treatment of Advanced Metastatic Prostate Cancer Undergoing Chemotherapy - an Exploratory Randomized Controlled Trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

Prostate cancer is in Germany with approximately 25% of all cancers the most common cancer
among man. Assumably there will be an increase in prostate cancer in the next few years
because of demographic factors. The progressive metastatic prostate cancer often develops an
androgen resistance. This so-called Castration-Resistant Prostate Cancer (CRPC) is not
responsive to androgen deprivation therapy. Depending on symptoms and progression first-line
chemotherapy - docetaxel and abiraterone are available.

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.

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Organizational Data

  •   DRKS00010339
  •   2017/04/27
  •   2016/02/09
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02710721  (ClinicalTrials.gov)
  •   ProstateDiet  (Charite University, Berlin, Germany)
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Health Condition or Problem studied

  •   Fasting
  •   Prostatic Neoplasms
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Other: Fasting
  •   Other: Control
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- FACT-P/-Taxane/-An sum score; time frame: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16); summarized change of FACT score from baseline to day 8 after each chemotherapy

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Secondary Outcome

- FACT-P/-Taxane/-An sum score; time frame: Assessment day 0 (baseline) and 3 and 6 months after day 0; Change of score after 3 and 6 months
- HADS; time frame: 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; Summarized change of score for all time Points

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2016/04/30
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   25   Years
  •   80   Years
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Additional Inclusion Criteria

- Diagnosis of CRPC or hormone-sensitive prostate cancer with high metastatic load (1≥
visceral and ≥4 osseous metastases)

- Cancer is treated to guidelines conventionally with chemotherapy or with a
combination of hormone therapy and chemotherapy.

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Exclusion Criteria

- 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

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Addresses

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    • Charite University, Berlin, Germany
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    •   [---]*
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    • Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften
    • Andreas Michalsen, Prof. Dr. 
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    •   [---]*
    •   [---]*
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    • Andreas Michalsen, Prof. Dr. 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2017/02/20


* This entry means the parameter is not applicable or has not been set.