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

Primary Central Nervous System Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02983942
• Other study ID #: B0010
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: November 29, 2016
• Last updated: December 2, 2016
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: Beijing Tiantan Hospital
• Contact: Song Lin, M.D.
• Phone: 861067096509
• Email: linsong2005[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

Dietary Supplement:
• ketogenic diet
Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.
• Routine diet
Routine diet is given without blood ketone requirement

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The chemosensitivity of tumor	The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI)	Two years	No
Secondary	Long term effect of chemotherapy	The average time from complete remission of tumor to relapse	Two years	No
Secondary	overall survival	Participants will be followed until reported death to calculate overall survival	Three years	No
Secondary	Quality of life	Short Form 36 Questionnaire will be used to assess patients' quality of life	Two years	No