N/A N=50 Randomized Treatment

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

Recurrent Glioblastoma

Bottom Line

View on ClinicalTrials.gov: NCT01754350 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Progression-free-survival — 20; 16 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: calorie-restricted ketogenic diet and transient fasting (Dietary_supplement); standard nutrition (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johann Wolfgang Goethe University Hospital
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-free-survival	—	—
SECONDARY Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9	—	—
SECONDARY Safety and Tolerability as Defined as Number of Patients With Adverse Events	—	—
SECONDARY Progression-free-survival	—	—
SECONDARY Overall Survival	—	—
SECONDARY Frequency of Seizures	—	—
SECONDARY Ketosis	—	—
SECONDARY Quality of Life as Measured by the EORTC Quality of Life Questionnaire	—	—
SECONDARY Depression	—	—
SECONDARY Attention	—	—
SECONDARY Response	—	—

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. 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.

Eligibility Criteria

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)
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01754350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.