FastingNCT02710721
Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer
A study testing Fasting in people with Fasting and Prostatic Neoplasms, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 25 to 89 years, men only
- Conditions the study is for
- Fasting, Prostatic Neoplasms
- What is being tested?
- Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 89 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
Berlin, 12200
About this study
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
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.
Read the 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.
- Conditions
- Fasting, Prostatic Neoplasms
- Being tested
- Fasting, Control
- Keywords
- Fasting, Prostatic Neoplasms, Complementary Therapies, Urology
- Medical subject headings
- Fasting, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
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.
ControlOther
Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | 60h-modified fasting (36h before and 24h after chemotherapy) Receives: Other: Fasting |
| Control | Active comparator | mediterranean diet Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-P/-Taxane/-An sum score
summarized change of FACT score from baseline to day 8 after each chemotherapy
Measured: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)
Secondary outcomes (2)
FACT-P/-Taxane/-An sum score
Change of score after 3 and 6 months
Measured: Assessment day 0 (baseline) and 3 and 6 months after day 0
HADS
Summarized change of score for all time Points
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2020
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: GesundheitswissenschaftenKurt Miller, Prof. Dr., Principal investigator, Charité Centrum Chirurgische Medizin, CC 8 Klinik für UrologieUrsula Steiner, Dr., Principal investigator, Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710721
- Sponsor's protocol ID
- ProstateDiet
- Status last verified
- Dec 2022
- First submitted
- 9 Feb 2016
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02710721
- Acronym / sponsor ID
- ProstateDiet
- Conditions
- Fasting, Prostatic Neoplasms
- Keywords
- Fasting, Prostatic Neoplasms, Complementary Therapies, Urology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Other: Fasting60h-modified fasting (36h before and 24h after chemotherapy) |
| Control | Active comparator | Other: Controlmediterranean diet |
Who may qualify
- Ages
- 25 to 89 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FastingPatients 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. | Other | Fasting |
| ControlParticipants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet. | Other | Control |
Primary outcome
FACT-P/-Taxane/-An sum score
Time frame: 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
2 secondary outcomes
FACT-P/-Taxane/-An sum score
Time frame: Assessment day 0 (baseline) and 3 and 6 months after day 0
HADS
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof. Dr. principal investigator
Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften
Kurt Miller, Prof. Dr. principal investigator
Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
Ursula Steiner, Dr. principal investigator
Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Fasting and Prostatic Neoplasms, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT-P/-Taxane/-An sum score (time frame: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.