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

NCT02939378 | Unknown Phase 1

• 1 other identifier: B0009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma Multiforme

Keywords

ketogenic diet; recurrent glioblastoma; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-emergent Adverse Effects

  Number of participants with treatment-emergent adverse effects while on ketogenic diet.

  one year

Secondary Outcomes (4)

• The Chemosensitivity of Tumor

  one year

• Overall Survival

  one year

• Ketosis

  one year

• Quality of Life

  one year

Study Arms (2)

ketogenic diet group

EXPERIMENTAL

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

Standard diet group

OTHER

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

Interventions

Ketogenic diet DIETARY_SUPPLEMENT

Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

ketogenic diet group

Standard diet DIETARY_SUPPLEMENT

Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

Standard diet group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60
• Karnovsky Performance Score of 60 or more.
• histologically confirmed glioblastoma multiforme, grade 4
• Ability and willingness to signed informed consent form.
• Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy.
• normal function of liver and kidney

You may not qualify if:

• 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
• History of uncontrolled hyperlipidemia or hyperglycemia.
• History of human immunodeficiency virus, or hepatitis C
• Pregnancy or breastfeeding
• Inability or unwillingness of subject to give written informed consent

Sponsors & Collaborators

• Song Lin: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Song Lin, M.D.,

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Lin, M.D.,

CONTACT

+8601067096509; linsong2005@126.com

Xiaohui Ren, M.D.,

CONTACT

+8601067096509; xiaohuiren@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 20, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 20, 2016

Record last verified: 2016-10

Locations

CN (1)