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

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ClinicalTrials.gov Identifier: NCT02939378
Recruitment Status : Unknown
Verified October 2016 by Song Lin, Beijing Tiantan Hospital.
Recruitment status was:  Recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Song Lin, Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE October 6, 2016
First Posted Date  ICMJE October 20, 2016
Last Update Posted Date October 20, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Number of Participants with Treatment-emergent Adverse Effects [ Time Frame: one year ]
Number of participants with treatment-emergent adverse effects while on ketogenic diet.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study
Official Title  ICMJE Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Ketogenic diet
  • 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.
    Intervention: Dietary Supplement: Standard diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02939378
Other Study ID Numbers  ICMJE B0009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Song Lin, Beijing Tiantan Hospital
Study Sponsor  ICMJE Song Lin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Song Lin, M.D., Beijing Tiantan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP