Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study

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

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in vitro.

Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic adjuvant to salvage chemotherapy for recurrent glioblastoma.

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Detailed Description

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Diet change by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and inhibit tumor growth.

In a pilot of recurrent glioblastoma, ketogenic diet adjuvant salvage chemotherapy was given as interventional group and standard diet adjuvant salvage chemotherapy was given as control group.

The study examines whether a ketogenic diet adjunctive to salvage chemotherapy can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.

Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ketogenic diet group

Ketogenic diet adjuvant to salvage chemotherapy was given to recurrent glioblastoma. Blood glucose and ketone were kept more than 2mmol/L during salvage chemotherapy. The side effect was observed and recorded. Tumor volume was monitored and the efficacy was recorded.

Group Type EXPERIMENTAL

Ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

Standard diet group

Standard diet adjuvant to salvage chemotherapy was given to recurrent glioblastoma. Blood glucose and ketone were recorded during salvage chemotherapy. The side effect was observed and recorded. Tumor volume was monitored and the efficacy was recorded.

Group Type OTHER

Standard diet

Intervention Type DIETARY_SUPPLEMENT

Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

Interventions

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Ketogenic diet

Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

Intervention Type DIETARY_SUPPLEMENT

Standard diet

Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Age 18-60
2. Karnovsky Performance Score of 60 or more.
3. histologically confirmed glioblastoma multiforme, grade 4
4. Ability and willingness to signed informed consent form.
5. Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy.
6. normal function of liver and kidney

Exclusion Criteria

1. Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
2. History of uncontrolled hyperlipidemia or hyperglycemia.
3. History of human immunodeficiency virus, or hepatitis C
4. Pregnancy or breastfeeding
5. Inability or unwillingness of subject to give written informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No