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

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 Overview

• Status: Unknown
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Dietary supplement: Ketogenic diet; Dietary supplement: Standard diet

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Song Lin, M.D.,; Phone Number: +8601067096509; Email: linsong2005@126.com
      • Contact: Xiaohui Ren, M.D.,; Phone Number: +8601067096509; Email: xiaohuiren@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.	Dietary supplement: Standard diet; Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Song Lin
• Investigators: Principal Investigator: Song Lin, M.D.,, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 20, 2016

Study Record Updates

• Last Update Posted (Estimate): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: chemotherapy; ketogenic diet; recurrent glioblastoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: B0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED