The Effect of Ketogenic Diet on Malignant Tumors- Recurre... | NCT01092247

Studies
The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress

NCT01092247

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Mar 24, 2010Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Malignant Tumors

Interventions

Nutritional support with Standard diet
Nutritional intervention with the Ketogenic diet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

May 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Mar 15, 2010

First Submission Date that Met QC Criteria

Mar 23, 2010

First Posted Date

Mar 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2010

Last Update Posted Date

Mar 24, 2010Estimated

Name	Class
Nutricia Liverpool	INDUSTRY

Description Module

Brief Summary

The aim of the study is, to study the efficacy of the ketogenic diet in delaying or preventing recurrence and tumor growth progression of patients who have been previously treated by concomitant chemoradiotherapy (6 months) for high-grade glial tumors.

It will be an open-label trial of nutritional intervention for up to 1 year. An interim analysis of the data will be carried out to assess safety, compliance and efficacy of the diet. This will be reviewed by both SHS and the Clinical trial team.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard diet: Nutritional support	Placebo Comparator		Other: Nutritional support with Standard diet
Nutritional intervention: Ketogenic diet.	Experimental		Other: Nutritional intervention with the Ketogenic diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutritional support with Standard diet	Other	Nutritional support with Standard diet	Standard diet: Nutritional support

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To study the effect of the ketogenic diet on tumor growth progression and longevity in patients with Malignant glioblastoma.	This will be done by comparing tumor size by repeated MRI studies (every 2 months)

Secondary Outcomes

Measure	Description	Time Frame
Quality of life	Performance scale and quality of life evaluation (Karnofsky and EQ5D scale)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Consenting adults aged ≥ 18 years.
Recurrent or progressive high grade glioma after failure of at least one line of standard oncological treatment.
Gliomatosis cerebri, including patients declining radiation treatment.

Exclusion criteria:

Patients with malignant tumors who are receiving treatment at the time of the recruitment.
Early termination - patients who will wish to stop their participation in the trial will discontinue the ketogenic diet and return to their usual diet.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nachum Vaisman, Prof'	Contact	009-972-3-6974807		vaisman@tasmc.health.gov.il

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018529	Nutritional Support

Ancestor Terms

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided