Clinical trial · Interventional
Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fasting | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| Fasting | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fasting
- description
- 60h-modified fasting (36h before and 24h after chemotherapy)
- interventionNames
- Other: Fasting
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- mediterranean diet
- interventionNames
- Other: Control
Primary outcomes (1)
- measure
- FACT-P/-Taxane/-An sum score
- timeFrame
- Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 25 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available