Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710721
• Other study ID #: ProstateDiet
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2022

Study information

• Verified date: December 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2022
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasting
• Prostatic Neoplasms

Intervention

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.
• Control
Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.

Locations

Country	Name	City	State
Germany	Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differential blood count	Summarized changes of 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
Other	Intensity of chemotherapy- related side effects	Group difference of summarized frequency and intensity	Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)
Primary	FACT-P/-Taxane/-An sum score	summarized change of FACT score from baseline to day 8 after each chemotherapy	Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)
Secondary	FACT-P/-Taxane/-An sum score	Change of score after 3 and 6 months	Assessment day 0 (baseline) and 3 and 6 months after day 0
Secondary	HADS	Summarized change of score for all time Points	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