Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Fasting, Prostatic Neoplasms

Intervention / Treatment
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* Other: Fasting
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting<br>60h-modified fasting (36h before and 24h after chemotherapy) | Other: Fasting<br>* 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.<br>|
| Active Comparator: Control<br>mediterranean diet | Other: Control<br>* Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACT-P/-Taxane/-An sum score | Change of score after 3 and 6 months | Assessment day 0 (baseline) and 3 and 6 months after day 0 | 
| HADS | Summarized change of score for all time Points | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fasting, Prostatic Neoplasms, Complementary Therapies, Urology