NCT02983942

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

1.9 years

First QC Date

November 29, 2016

Last Update Submit

December 2, 2016

Conditions

Primary Central Nervous System Lymphoma

Keywords

ketogenic dietPrimary Central Nervous System Lymphomachemotherapy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment related adverse events as assessed by CTCAE v4.0

    The number and incidence (%) of treatment related adverse events among participants

    Two years

Secondary Outcomes (4)

  • The chemosensitivity of tumor

    Two years

  • Long term effect of chemotherapy

    Two years

  • overall survival

    Three years

  • Quality of life

    Two years

Study Arms (2)

ketogenic diet group

EXPERIMENTAL

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

routine diet group

ACTIVE COMPARATOR

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

Interventions

ketogenic dietDIETARY_SUPPLEMENT

Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.

ketogenic diet group
Routine dietDIETARY_SUPPLEMENT

Routine diet is given without blood ketone requirement

routine diet group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70
  • Histopathologically confirmed PCNSL
  • No systemic involvement
  • Ability and willingness to sign informed consent
  • Normal liver and kidney function
  • Karnofsky Performance Score of 60 or more

You may not qualify if:

  • Any systemic involvement of the tumor
  • 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
  • Uncontrolled hyperlipidemia or hyperglycemia
  • Human immunodeficiency virus positive, or hepatitis C positive
  • Pregnancy of breastfeeding
  • Inability or unwillingness to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Interventions

Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Song Lin, M.D.

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Lin, M.D.

CONTACT

861067096509linsong2005@126.com

Chun Zeng, M.D.

CONTACT

861067096509zengchun79@aliyun.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 6, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

CN(1)