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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

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.

Interventions

  • Dietary Supplement: Ketogenic diet
    • Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
  • Dietary Supplement: Standard diet
    • Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Song Lin
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Song Lin, Proffessor – Beijing Tiantan Hospital
  • Overall Official(s)
    • Song Lin, M.D.,, Principal Investigator, Beijing Tiantan Hospital
  • Overall Contact(s)
    • Song Lin, M.D.,, +8601067096509, linsong2005@126.com

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