Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02710721

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

FACT-P/-Taxane/-An sum score [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

FACT-P/-Taxane/-An sum score [Assessment day 0 (baseline) and 3 and 6 months after day 0]
Change of score after 3 and 6 months
HADS [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

Differential blood count [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
Intensity of chemotherapy- related side effects [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 89 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie	Berlin		Germany	12200

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

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