Trial Outcomes & Findings for Ketogenic Diet for Recurrent Glioblastoma (NCT NCT00575146)

Results Overview

percentage of patients who discontinued diet due to intolerability

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

until progression for up to 12 months

Results posted on

2014-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	Ketogenic Diet unrestricted ketogenic diet (\< 50-60 g carbohydrates per day) and dietary supplementary products provided by Tavarlin
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketogenic Diet for Recurrent Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketogenic Diet n=20 Participants ketogenic diet
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	6 Participants n=99 Participants
Age, Continuous	55 years STANDARD_DEVIATION 12.2 • n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants
Region of Enrollment Germany	20 participants n=99 Participants

PRIMARY outcome

Timeframe: until progression for up to 12 months

percentage of patients who discontinued diet due to intolerability

Outcome measures

Outcome measures
Measure	Ketogenic Diet n=20 Participants unrestricted ketogenic diet
Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability	15 percent of participants

SECONDARY outcome

Timeframe: until progression for up to 12 months

Population: for the analyis of PFS and OS, 3 patients who discontinued the diet in the absence of progression were excluded

measured by Macdonald-Criteria

Outcome measures

Outcome measures
Measure	Ketogenic Diet n=17 Participants unrestricted ketogenic diet
Progression-free-survival	5 weeks Interval 3.0 to 13.0

SECONDARY outcome

Timeframe: death/last contact, an average of about 1 year

Participants were followed until reported death or last contact until 05/2011

Outcome measures

Outcome measures
Measure	Ketogenic Diet n=20 Participants unrestricted ketogenic diet
Overall Survival	32 weeks Interval 6.0 to 159.0

SECONDARY outcome

Timeframe: while on study treatment for up to 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: while on study treatment for up to 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: while on study treatment for up to 12 months

Outcome measures

Outcome data not reported

Adverse Events

Ketogenic Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Johannes Rieger

Dr. Senckenberg Institute of Neurooncology

Phone: +49 69 6301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place