Fasting, Prostatic Neoplasms
Conditions
Keywords
Fasting, Prostatic Neoplasms, Complementary Therapies, Urology
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.
Interventions
OTHERFasting
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.
OTHERControl
Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed