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Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study


N/A
18 Years
N/A
Open (Enrolling)
Both
Recurrent Glioblastoma

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Trial Information

Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free-survival

Outcome Description:

Progression-free-survival rates 6 months after reirradiation

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

Germany: Ethics Commission

Study ID:

ERGO2

NCT ID:

NCT01754350

Start Date:

May 2013

Completion Date:

October 2015

Related Keywords:

  • Recurrent Glioblastoma
  • ketogenic diet
  • glioma
  • fasting
  • reirradiation
  • nutrition
  • Glioblastoma

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