verification of ketogenic diet for lung cancer

JRCT ID: jRCTs051210119

Registered date:09/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lung Cancer
• Date of first enrollment: 12/01/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): ketogenic diet regimen using MCT combination beverage and MCT oil

Outcome(s)

Primary Outcome

1)Number and rate of adverse events of Grade 3 or higher up to 16 weeks
2)Continuation rate of ketognic diet at 16 weeks

Secondary Outcome

1)Overall Survival
2)Progression-Free Survival
3)Duration of treatment at the time of participation in the study
4)Changes in scores of JFS and of Barthel Index
5)Changes in scores of EQ-5D and of FACT-L
6)Changes in scores of resilience scale
7)Body composition index (muscle mass, skeletal muscle index / SMI, body weight, fat mass (body fat mass / body fat percentage), extracellular water ratio, extracellular water content, phase angle, BMI)
8)Changes in Blood glucose monitoring
9)Changes in ABC score
10)Changes in Gut microbiota
11)Changes in Blood tumor marker

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1)Patients who obtained written consent for this study
2)Patients who are 18 years old or older and under 80 years old at the time of informed consent
3)Patients who diagnosed with non-small cell lung cancer (NSCLC)
4)Patients whose clinical stage is stage IIIb or stage IV
5)Patients who undergoing standard lung cancer treatment
6)Patients whose PS (Performance Status) is 0-2

Exclude criteria

1)Patients with diabetes who require treatment
2)Patients who have allergic episode with milk components
3)Patients who have difficulty ingesting orally
4)Patients who have difficulty in outpatient visits
5)Patients who are participating in or are planning to participate in clinical trials or other clinical studies
6)Patients who are considered ineligible to participate by principal investigator or sub-investigator

Related Information

• Primary Sponsor: Hagihara Keisuke
• Source(s) of Monetary Support: Meiji Holdings Co.,The Nisshin OilliO Group, Ltd.,Co-creation Bureau, Osaka University