Ketogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma

December 2, 2016 updated by: Song Lin, Beijing Tiantan Hospital

Ketogenic Diet Adjunctive to High Dose Methotrexate Chemotherapy for Primary Central Nervous System Lymphoma

Ketogenic diet has shown auxiliary effect on treatment of malignant tumors require high glucose consumption. This study is designed to evaluate the safety and efficacy of ketogenic diet adjunctive to high dose methotrexate(HD-MTX) chemotherapy for primary central nervous system lymphoma (PCNSL).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In a pilot study of primary central nervous system(CNS) lymphoma patients, ketogenic diet was given in adjunction with standard HD-MTX chemotherapy as interventional group; standard HD-MTX is given with routine diet as control group. The primary endpoint is the safety of ketogenic diet in PCNSL patients receiving chemotherapy, secondary endpoints include rate of complete remission, remission time, rate of tumor relapse and overall survival.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-70
  2. Histopathologically confirmed PCNSL
  3. No systemic involvement
  4. Ability and willingness to sign informed consent
  5. Normal liver and kidney function
  6. Karnofsky Performance Score of 60 or more

Exclusion Criteria:

  1. Any systemic involvement of the tumor
  2. Systemic illness or medical condition may pose additional risk, including cardiac, metabolic or endocrine disorders; incompensated renal or liver disfunction; history of renal calculi, hyperuricemia, hyper calcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
  3. Uncontrolled hyperlipidemia or hyperglycemia
  4. Human immunodeficiency virus positive, or hepatitis C positive
  5. Pregnancy of breastfeeding
  6. Inability or unwillingness to give written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ketogenic diet group
Ketogenic diet is given in combination to standard HD-MTX chemotherapy to primary central nervous system lymphoma patients. Blood ketone is kept no less than 2mmol/L during the initial 4 cycles of chemotherapy. The adverse events is monitored and recorded. Tumor response is evaluated and recorded.
Dietary supplement: ketogenic diet
Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.
Active Comparator: routine diet group
Standard HD-MTX chemotherapy is given with routine diet.Blood ketone is measured and recorded. The adverse events is monitored and recorded. Tumor response is evaluated and recorded.
Dietary supplement: Routine diet
Routine diet is given without blood ketone requirement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Time Frame: Two years
The number and incidence (%) of treatment related adverse events among participants
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The chemosensitivity of tumor
Time Frame: Two years
The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI)
Two years
Long term effect of chemotherapy
Time Frame: Two years
The average time from complete remission of tumor to relapse
Two years
overall survival
Time Frame: Three years
Participants will be followed until reported death to calculate overall survival
Three years
Quality of life
Time Frame: Two years
Short Form 36 Questionnaire will be used to assess patients' quality of life
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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