Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Recurrent Glioblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ketogenic diet and transient fasting

Calorie-restricted, ketogenic diet and transient fasting during reirradiation

Group Type EXPERIMENTAL

calorie-restricted ketogenic diet and transient fasting

Intervention Type 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".

standard nutrition

nutrition according to recommendations of the German society for nutrition during reirradiation

Group Type ACTIVE_COMPARATOR

standard nutrition

Intervention Type DIETARY_SUPPLEMENT

nutrition as recommended by the german society for nutrition, 30 kcal/kg per day

Interventions

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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".

Intervention Type DIETARY_SUPPLEMENT

standard nutrition

nutrition as recommended by the german society for nutrition, 30 kcal/kg per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No