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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Standard diet: Nutritional support

Group Type PLACEBO_COMPARATOR

Nutritional support with Standard diet

Intervention Type OTHER

Nutritional support with Standard diet

Nutritional intervention: Ketogenic diet.

Group Type EXPERIMENTAL

Nutritional intervention with the Ketogenic diet

Intervention Type OTHER

Nutritional intervention with ketogenic diet. The Diet plan will be based on each patient individually according to his nutritional needs. Age, weight, activity levels, culture and food preferences are taken in consideration

Interventions

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Nutritional support with Standard diet

Intervention Type OTHER

Nutritional intervention with the Ketogenic diet

Nutritional intervention with ketogenic diet. The Diet plan will be based on each patient individually according to his nutritional needs. Age, weight, activity levels, culture and food preferences are taken in consideration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No