Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer

Not Applicable

Completed

• Conditions: Fasting; Prostatic Neoplasms
• Interventions: Other: Control; Other: Fasting

• Registration Number: NCT02710721
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-17
• Study Start: 2016-04
• Primary Completion: 2020-07
• Status Verified: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	mediterranean diet
Fasting	Fasting	60h-modified fasting (36h before and 24h after chemotherapy)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie; 🇩🇪 Berlin, Germany