A short-term ketogenic diet combined with 24-hour fasting and chemoprotection for patients with acute myeloid leukaemia

Not Applicable

• Conditions: acute myeloid leukemia; chemotherapy toxicity; second malignancies; Diet and Nutrition - Other diet and nutrition disorders; Infection - Studies of infection and infectious agents; Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12620000850976
• Lead Sponsor: epean Blue Mountains Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-27
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

•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

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified