An interventional study of Fasting and Control in Fasting and Prostatic Neoplasms, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to male participants aged 25 Years to 89 Years. Per ClinicalTrials.gov, last updated 2022-12-13.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Supportive care
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.
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.
86 studies on the registry are indexed under Fasting; 38 are open to participants now.
This study's enrollment of 49 is below the median of 60 across 66 interventional studies indexed under Fasting.
Browse Fasting studies →Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.
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Exclusion Criteria:
60h-modified fasting (36h before and 24h after chemotherapy)
Other: Fasting
mediterranean diet
Other: Control
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.
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
summarized change of FACT score from baseline to day 8 after each chemotherapy
Time frame: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)
FACT-P/-Taxane/-An sum score
Change of score after 3 and 6 months
Time frame: Assessment day 0 (baseline) and 3 and 6 months after day 0
HADS
Summarized change of score for all time Points
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
Differential blood count
Summarized changes of 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
Intensity of chemotherapy- related side effects
Group difference of summarized frequency and intensity
Time frame: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2016 to primary completion in Jul 2020, 51 months.
Of 42 non-industry interventional studies with no phase under Fasting, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 51 months is above that.
Counting every sponsor, half of 43 studies reached it within 31 months; a quarter within 10 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany →