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

Phase 1

• Conditions: Primary Central Nervous System Lymphoma
• Interventions: Dietary Supplement: ketogenic diet; Dietary Supplement: Routine diet

• Registration Number: NCT02983942
• Lead Sponsor: Beijing Tiantan Hospital

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).

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 Timeline

• Study First Submitted: 2016-11-29
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-02
• Last Update Submitted: 2016-12-02
• Study First Posted: 2016-12-06
• Last Update Posted: 2016-12-06
• Study Start: 2017-01
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketogenic diet group	ketogenic diet	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.
routine diet group	Routine diet	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment related adverse events as assessed by CTCAE v4.0	Two years	The number and incidence (%) of treatment related adverse events among participants

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China