NCT02983942

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ketogenic diet	Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.
DIETARY_SUPPLEMENT	Routine diet	Routine diet is given without blood ketone requirement

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2016-12-06
• Last updated: 2016-12-06

Locations

1 site across 1 country: China