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Trial record 3 of 12 for:    Ketogenic AND GBM

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

This study is currently recruiting participants.
Verified October 2016 by Song Lin, Beijing Tiantan Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02939378
First Posted: October 20, 2016
Last Update Posted: October 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Song Lin, Beijing Tiantan Hospital
  Purpose

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.


Condition Intervention Phase
Glioblastoma Multiforme Dietary Supplement: Ketogenic diet Dietary Supplement: Standard diet Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study

Resource links provided by NLM:


Further study details as provided by Song Lin, Beijing Tiantan Hospital:

Primary Outcome 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 Outcome 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


Estimated Enrollment: 60
Study Start Date: October 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: Ketogenic diet
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.
Dietary Supplement: Standard diet
Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939378


Contacts
Contact: Song Lin, M.D., +8601067096509 linsong2005@126.com
Contact: Xiaohui Ren, M.D., +8601067096509 xiaohuiren@aliyun.com

Locations
China, Beijing
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100005
Contact: Song Lin, M.D.,    +8601067096509    linsong2005@126.com   
Contact: Xiaohui Ren, M.D.,    +8601067096509    xiaohuiren@aliyun.com   
Sponsors and Collaborators
Song Lin
Investigators
Principal Investigator: Song Lin, M.D., Beijing Tiantan Hospital
  More Information

Responsible Party: Song Lin, Proffessor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02939378     History of Changes
Other Study ID Numbers: B0009
First Submitted: October 6, 2016
First Posted: October 20, 2016
Last Update Posted: October 20, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Song Lin, Beijing Tiantan Hospital:
ketogenic diet
recurrent glioblastoma
chemotherapy

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue