Trial Outcomes & Findings for Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma (NCT NCT01754350)

Results Overview

Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

6 months

Results posted on

2021-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	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".	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
Overall Study STARTED	25	25
Overall Study COMPLETED	20	22
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketogenic Diet and Transient Fasting n=25 Participants 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".	Standard Nutrition n=25 Participants 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	Total n=50 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	58 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Germany	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)

Outcome measures

Outcome measures
Measure	Ketogenic Diet and Transient Fasting n=20 Participants 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".	Standard Nutrition n=22 Participants 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
Progression-free-survival	20 percentage of participants	16 percentage of participants

SECONDARY outcome

Timeframe: day 1-12

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1-12

Safety and tolerability of the calorie-restricted, ketogenic diet and the transient fasting as defined as number of patients with adverse events

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month, 3 months

progression-free-survival rates 1 month and 3 month after reirradiation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

overall survival after the reirradiation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1-12

frequency of seizures at day 1-12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1-12

urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1-12

Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1-12

depression as measured by SCL-90 at day 1-12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1-12

attention as measured by d2-testing at day 1-12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

response assessment 1 month after reirradiation

Outcome measures

Outcome data not reported

Adverse Events

Ketogenic Diet and Transient Fasting

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard Nutrition

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketogenic Diet and Transient Fasting n=20 participants at risk 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".	Standard Nutrition n=22 participants at risk 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
Nervous system disorders epileptic seizure	5.0% 1/20 • Number of events 1 • 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.	9.1% 2/22 • Number of events 2 • 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.
Nervous system disorders Others	15.0% 3/20 • Number of events 3 • 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.	13.6% 3/22 • Number of events 3 • 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.

Additional Information

Johannes Rieger

JohannWGUH

Phone: +4969630187711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place