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| Name | Class |
|---|---|
| Tavarlin | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketogenic diet and transient fasting | Experimental | Calorie-restricted, ketogenic diet and transient fasting during reirradiation |
|
| standard nutrition | Active Comparator | nutrition according to recommendations of the German society for nutrition during reirradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calorie-restricted ketogenic diet and transient fasting | Dietary 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". |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free-survival | Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day 1-12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Senckenberg Institute of Neurooncology | Frankfurt | Germany | ||||
| University of Tuebingen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34487222 | Derived | 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. | |
| 33512717 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketogenic Diet and Transient Fasting | Calorie-restricted, ketogenic diet and transient fasting during reirradiation calorie-restricted ketogenic diet and transient fasting: 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". |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2016 |
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|
| standard nutrition | Dietary Supplement | nutrition as recommended by the german society for nutrition, 30 kcal/kg per day |
|
| 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 | day 1-12 |
| Progression-free-survival | progression-free-survival rates 1 month and 3 month after reirradiation | 1 month, 3 months |
| Overall Survival | overall survival after the reirradiation | 12 months |
| Frequency of Seizures | frequency of seizures at day 1-12 | day 1-12 |
| Ketosis | urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12 | 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 | day 1-12 |
| Depression | depression as measured by SCL-90 at day 1-12 | day 1-12 |
| Attention | attention as measured by d2-testing at day 1-12 | day 1-12 |
| Response | response assessment 1 month after reirradiation | 1 month |
| Tübingen |
| Germany |
| Allaf 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. |
| 32619561 | Derived | Voss 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. |
| FG001 | Standard Nutrition | nutrition according to recommendations of the German society for nutrition during reirradiation standard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketogenic Diet and Transient Fasting | Calorie-restricted, ketogenic diet and transient fasting during reirradiation calorie-restricted ketogenic diet and transient fasting: 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". |
| BG001 | Standard Nutrition | nutrition according to recommendations of the German society for nutrition during reirradiation standard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free-survival | Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO) | Posted | Number | percentage of participants | 6 months |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | day 1-12 | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | day 1-12 | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Progression-free-survival | progression-free-survival rates 1 month and 3 month after reirradiation | Not Posted | 1 month, 3 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | overall survival after the reirradiation | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Seizures | frequency of seizures at day 1-12 | Not Posted | day 1-12 | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Ketosis | urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12 | Not Posted | day 1-12 | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | day 1-12 | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Depression | depression as measured by SCL-90 at day 1-12 | Not Posted | day 1-12 | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Attention | attention as measured by d2-testing at day 1-12 | Not Posted | day 1-12 | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Response | response assessment 1 month after reirradiation | Not Posted | 1 month | Participants |
All, even non-serious adverse events, were monitored at start of treatment until end of intervention at day 12 to assess procedure-specific adverse events. After day 12, the prespecified secondary end point and adverse event "epileptic seizures"), and all serious adverse events were documented until the end of the study of individual patients (until primary end points was reached).
Few minor adverse events are not listed seperately because some of these occured in the same patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketogenic Diet and Transient Fasting | Calorie-restricted, ketogenic diet and transient fasting during reirradiation calorie-restricted ketogenic diet and transient fasting: 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". | 0 | 20 | 0 | 20 | 4 | 20 |
| EG001 | Standard Nutrition | nutrition according to recommendations of the German society for nutrition during reirradiation standard nutrition: nutrition as recommended by the german society for nutrition, 30 kcal/kg per day | 0 | 22 | 0 | 22 | 5 | 22 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epileptic seizure | Nervous system disorders | Systematic Assessment |
| ||
| Others | Nervous system disorders | Systematic Assessment | headache, nausea or possible epileptic seizures with short lasting aphasia |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johannes Rieger | JohannWGUH | +4969630187711 | j.rieger@uni-tuebingen.de |
| May 2, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|