Recurrent GlioblastomaERGO2NCT01754350
Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma
A study testing calorie-restricted ketogenic diet and transient fasting and standard nutrition in people with Recurrent Glioblastoma, run by Johann Wolfgang Goethe University Hospital at 2 sites in Germany.
Trial summary
Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- calorie-restricted ketogenic diet and transient fasting and standard nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- May 2013to Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >= 18 years
- recurrence of a histologically confirmed glioblastoma or gliosarcoma
- at least 6 months after first surgery
- at least 6 months after first radiotherapy
- interdisciplinary recommendation for reirradiation
- karnofsky performance status >= 60, ECOG <= 2
- creatinine <= 2,0 mg/dl, urea <= 100 mg/dl
- ALAT, ASAT <= 7x upper normal limit
Who cannot join
- bowel obstruction, subileus
- insulin-dependent diabetes
- decompensated heart failure (NYHA > 2)
- myocardial infarction within the last 6 months, symptomatic atrial fibrillation
- severe acute infection
- malnutrition, cachexia
Show all 11Show fewer
- other medical conditions that might increase the risk of the dietary intervention
- pregnancy
- uncontrolled thyroid function
- pancreatic insufficiency
- dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Dr. Senckenberg Institute of Neurooncology
Frankfurt
University of Tuebingen
Tübingen
About this study
Official title: Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study
Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. In preclinical models, restricting glucose availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor growth.
Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic diet and transient fasting can enhance the efficacy of reirradiation in patients with recurrent glioblastoma.
- Conditions
- Recurrent Glioblastoma
- Being tested
- calorie-restricted ketogenic diet and transient fasting, standard nutrition
- Keywords
- ketogenic diet, glioma, fasting, reirradiation, nutrition
- Medical subject headings
- Glioblastoma, Glioma, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calorie-restricted ketogenic diet and transient fastingDietary supplement
On day 1-3 and day 7-9, restriction of carbohydrates to < 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by "Tavarlin".
standard nutritionDietary supplement
nutrition as recommended by the german society for nutrition, 30 kcal/kg per day
| Study group | Role | What they receive |
|---|---|---|
| ketogenic diet and transient fasting | Experimental | Calorie-restricted, ketogenic diet and transient fasting during reirradiation Receives: Dietary Supplement: calorie-restricted ketogenic diet and transient fasting |
| standard nutrition | Active comparator | nutrition according to recommendations of the German society for nutrition during reirradiation Receives: Dietary Supplement: standard nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free-survival
Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)
Measured: 6 months
Secondary outcomes (10)
Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9
Feasibility of the calorie-restricted, ketogenic diet and the transient fasting measured as median number of days on diet per patient and average calorie and carbohydrate intake per day during day 1-9
Measured: day 1-12
Safety and Tolerability as Defined as Number of Patients With Adverse Events
Safety and tolerability of the calorie-restricted, ketogenic diet and the transient fasting as defined as number of patients with adverse events
Measured: day 1-12
Progression-free-survival
progression-free-survival rates 1 month and 3 month after reirradiation
Measured: 1 month, 3 months
Overall Survival
overall survival after the reirradiation
Measured: 12 months
Frequency of Seizures
frequency of seizures at day 1-12
Measured: day 1-12
Ketosis
urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12
Measured: day 1-12
Quality of Life as Measured by the EORTC Quality of Life Questionnaire
Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire
Measured: day 1-12
Depression
depression as measured by SCL-90 at day 1-12
Measured: day 1-12
Attention
attention as measured by d2-testing at day 1-12
Measured: day 1-12
Response
response assessment 1 month after reirradiation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startMay 2013
- Primary completionDec 2017
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tavarlin
- Responsible party
- Principal investigator, Johannes Rieger, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754350
- Sponsor's protocol ID
- ERGO2
- Acronym
- ERGO2
- Status last verified
- May 2021
- First submitted
- 14 Dec 2012
- Last updated
- 2 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Voss M, Wenger KJ, von Mettenheim N, Bojunga J, Vetter M, Diehl B, Franz K, Gerlach R, Ronellenfitsch MW, Harter PN, Hattingen E, Steinbach JP, Rodel C, Rieger J. Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial. Eur J Nutr. 2022 Feb;61(1):477-487. doi: 10.1007/s00394-021-02666-1. Epub 2021 Sep 6.
PubMed 34487222Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717Voss M, Wagner M, von Mettenheim N, Harter PN, Wenger KJ, Franz K, Bojunga J, Vetter M, Gerlach R, Glatzel M, Paulsen F, Hattingen E, Baehr O, Ronellenfitsch MW, Fokas E, Imhoff D, Steinbach JP, Rodel C, Rieger J. ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):987-995. doi: 10.1016/j.ijrobp.2020.06.021. Epub 2020 Jun 30.
PubMed 32619561
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study
- ClinicalTrials.gov ID
- NCT01754350
- Acronym / sponsor ID
- ERGO2 / ERGO2
- Conditions
- Recurrent Glioblastoma
- Keywords
- ketogenic diet, glioma, fasting, reirradiation, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Tavarlin
- Study start
- May 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 2 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. In preclinical models, restricting glucose availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor growth.
Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic diet and transient fasting can enhance the efficacy of reirradiation in patients with recurrent glioblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketogenic diet and transient fasting | Experimental | Dietary Supplement: calorie-restricted ketogenic diet and transient fastingCalorie-restricted, ketogenic diet and transient fasting during reirradiation |
| standard nutrition | Active comparator | Dietary Supplement: standard nutritionnutrition according to recommendations of the German society for nutrition during reirradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age >= 18 years
- recurrence of a histologically confirmed glioblastoma or gliosarcoma
- at least 6 months after first surgery
- at least 6 months after first radiotherapy
- interdisciplinary recommendation for reirradiation
Key exclusion criteria (11 listed)
- bowel obstruction, subileus
- insulin-dependent diabetes
- decompensated heart failure (NYHA > 2)
- myocardial infarction within the last 6 months, symptomatic atrial fibrillation
- severe acute infection
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 |
|---|---|---|
| calorie-restricted ketogenic diet and transient fastingOn day 1-3 and day 7-9, restriction of carbohydrates to < 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by "Tavarlin". | Dietary supplement | ketogenic diet and transient fasting |
| standard nutritionnutrition as recommended by the german society for nutrition, 30 kcal/kg per day | Dietary supplement | standard nutrition |
Primary outcome
Progression-free-survival
Time frame: 6 months
Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)
10 secondary outcomes
Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9
Time frame: day 1-12
Safety and Tolerability as Defined as Number of Patients With Adverse Events
Time frame: day 1-12
Progression-free-survival
Time frame: 1 month, 3 months
Overall Survival
Time frame: 12 months
Frequency of Seizures
Time frame: day 1-12
Ketosis
Time frame: day 1-12
Quality of Life as Measured by the EORTC Quality of Life Questionnaire
Time frame: day 1-12
Depression
Time frame: day 1-12
Attention
Time frame: day 1-12
Response
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34487222Voss M, Wenger KJ, von Mettenheim N, Bojunga J, Vetter M, Diehl B, Franz K, Gerlach R, Ronellenfitsch MW, Harter PN, Hattingen E, Steinbach JP, Rodel C, Rieger J. Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial. Eur J Nutr. 2022 Feb;61(1):477-487. doi: 10.1007/s00394-021-02666-1. Epub 2021 Sep 6.
- Derived from this study: PubMed 33512717Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Derived from this study: PubMed 32619561Voss M, Wagner M, von Mettenheim N, Harter PN, Wenger KJ, Franz K, Bojunga J, Vetter M, Gerlach R, Glatzel M, Paulsen F, Hattingen E, Baehr O, Ronellenfitsch MW, Fokas E, Imhoff D, Steinbach JP, Rodel C, Rieger J. ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):987-995. doi: 10.1016/j.ijrobp.2020.06.021. Epub 2020 Jun 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calorie-restricted ketogenic diet and transient fasting and standard nutrition in people with Recurrent Glioblastoma, run by Johann Wolfgang Goethe University Hospital at 2 sites 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 8 inclusion and 11 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 2 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free-survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01754350, which also lists 3 linked publications.
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 2 Jun 2021.