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Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02710721
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Fasting Prostatic Neoplasms Other: Fasting Other: Control Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Study Start Date : April 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Fasting
60h-modified fasting (36h before and 24h after chemotherapy)
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.

Active Comparator: Control
mediterranean diet
Other: Control
Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. Differential blood count [ 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 changes of blood count

  2. Intensity of chemotherapy- related side effects [ Time Frame: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16) ]
    Group difference of summarized frequency and intensity



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Ages Eligible for Study:   25 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710721


Contacts
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Contact: Andreas Michalsen, Prof. Dr. +49 30 80505 691 a.michalsen@immanuel.de

Locations
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Germany
Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie Recruiting
Berlin, Germany, 12200
Contact: Ursula Steiner, Dr.    +49 30 8445 2577    ursula.steiner@charite.de   
Contact: Kurt Miller, Prof. Dr.    +49 30 8445 2575    kurt.miller@charite.de   
Principal Investigator: Kurt Miller, Prof. Dr.         
Sub-Investigator: Ursula Steiner, Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: 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

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Responsible Party: Andreas Michalsen, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02710721     History of Changes
Other Study ID Numbers: ProstateDiet
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:
Fasting
Prostatic Neoplasms
Complementary Therapies
Urology
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases