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Completed

NCT Number: NCT02710721

Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer

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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Key information

Conditions

Fasting Behavior Feeding Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

25 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie

Berlin, 12200, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasting

Other

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

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Mar 17, 2016
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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