A phase II randomised controlled clinical trial in patients with acute myeloid leukaemia evaluating the effect on the incidence of major infection of a short-term ketogenic diet combined with 24-hour fasting compared to a standard hospital diet, before and during chemotherapy.

epean Blue Mountains Local Health District0 sites134 target enrollmentAugust 27, 2020

Overview

No summary available.

Registry

who.int

Start Date

August 27, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

epean Blue Mountains Local Health District

•Participant is willing and able to give informed consent for participation in the trial.
•Male or Female, aged 18\-75 years.
•Diagnosed with acute myeloid leukaemia.
•Scheduled to undergo at least 4 or more cycles of chemotherapy
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•Body mass index (BMI) \> 21 kg/m^2
•Weight loss \< 5% of body weight in the last 6 months
•Adequate renal function (serum creatinine \< 1\.5 X UNL \[upper normal limit] or creatinine clearance \> 50 ml/min)
•Ability to complete patient booklet by themselves or with assistance
•Ability and willingness to undergo short\-term ketogenic diet combined with short term fasting prior to and during chemotherapy

•Pregnant women.
•Nursing women.
•Diabetes mellitus undergoing therapy with insulin or oral agents
•History of low serum glucose (hypoglycaemia) or insulinoma
•History of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous
•History of significant cardiac disease, particularly uncompensated congestive heart failure New York Heart Association (NYHA) grade 2 or more or left ventricular ejection fraction (LVEF) \< 40% on any prior assessment.
•Psychiatric conditions that preclude adherence to study protocol
•Patients receiving parenteral nutrition
•Primary carnitine deficiency, carnitine palmitoyl transferase I or II deficiency, carnitine translocase deficiency, beta\-oxidation defects, medium\-chain acyl dehydrogenase deficiency, long\-chain acyl dehydrogenase deficiency, short\-chain acyl dehydrogenase deficiency, long\-chain 3\-hydroxyacyl\-CoA deficiency, medium\-chain 3\-hydroxyacyl\-CoA deficiency, pyruvate carboxylase deficiency, and porphyria.