Clinical trial NCT02710721: Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Prostatic Neoplasms
Keywords: Fasting
Prostatic Neoplasms
Complementary Therapies
Urology
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 49
Sex: MALE
Minimum age (years): 25
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: FACT-P/-Taxane/-An sum score
timeFrame: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)
Secondary outcomes:
measure: FACT-P/-Taxane/-An sum score
timeFrame: Assessment day 0 (baseline) and 3 and 6 months after day 0
measure: HADS
timeFrame: 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:
measure: Differential blood count
timeFrame: 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
measure: Intensity of chemotherapy- related side effects
timeFrame: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)
Locations:
city: Berlin
country: Germany
facility: Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
Study officials:
affiliation: Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
name: Kurt Miller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
name: Ursula Steiner, Dr.
role: PRINCIPAL_INVESTIGATOR
References: