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

Song Lin

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Glioblastoma Multiforme

Treatments: Dietary Supplement: Standard diet; Dietary Supplement: Ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02939378

B0009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

ketogenic diet group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Ketogenic diet

Standard diet group

Other group

Description:

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.

Treatment:

Dietary Supplement: Standard diet