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

Phase 1

• Conditions: Glioblastoma Multiforme
• Interventions: Dietary Supplement: Standard diet; Dietary Supplement: Ketogenic diet

• Registration Number: NCT02939378
• Lead Sponsor: Song Lin

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-18
• Last Update Submitted: 2016-10-18
• Study First Posted: 2016-10-20
• Last Update Posted: 2016-10-20
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard diet group	Standard diet	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.
ketogenic diet group	Ketogenic diet	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-emergent Adverse Effects	one year	Number of participants with treatment-emergent adverse effects while on ketogenic diet.

Secondary Outcome Measures

Name	Time	Method
The Chemosensitivity of Tumor	one year	MRI(Magnetic Resonance Imaging) will be used to measure changes in brain tumor size (cm\^2).
Overall Survival	one year	Participants were followed until reported death
Ketosis	one year	Urine and blood ketosis (mmol/L) were measured
Quality of Life	one year	quality of life measured by the Karnofsky Performance Scale

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China