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

Glioblastoma Multiforme Clinical Trial

— KGDinrGBM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02939378
• Other study ID #: B0009
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 6, 2016
• Last updated: October 18, 2016
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Beijing Tiantan Hospital
• Contact: Song Lin, M.D.,
• Phone: +8601067096509
• Email: linsong2005[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Song Lin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment-emergent Adverse Effects	Number of participants with treatment-emergent adverse effects while on ketogenic diet.	one year	Yes
Secondary	The Chemosensitivity of Tumor	MRI(Magnetic Resonance Imaging) will be used to measure changes in brain tumor size (cm^2).	one year	No
Secondary	Overall Survival	Participants were followed until reported death	one year	No
Secondary	Ketosis	Urine and blood ketosis (mmol/L) were measured	one year	No
Secondary	Quality of Life	quality of life measured by the Karnofsky Performance Scale	one year	No