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
|Condition or disease||Intervention/treatment||Phase|
|Fasting Prostatic Neoplasms||Other: Fasting Other: Control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
60h-modified fasting (36h before and 24h after chemotherapy)
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
Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.
- 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
- 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
- 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
- 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
- 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
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
|Contact: Andreas Michalsen, Prof. Dr.||+49 30 80505 email@example.com|
|Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie||Recruiting|
|Berlin, Germany, 12200|
|Contact: Ursula Steiner, Dr. +49 30 8445 2577 firstname.lastname@example.org|
|Contact: Kurt Miller, Prof. Dr. +49 30 8445 2575 email@example.com|
|Principal Investigator: Kurt Miller, Prof. Dr.|
|Sub-Investigator: Ursula Steiner, Dr.|
|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|