Preoperative Immuno-Nutritional Therapy for Lung Cancer

JRCT ID: jRCTs061240049

Registered date:02/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: lung cancer
• Date of first enrollment: 02/09/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Before surgery for lung cancer, take up to three 200 ml bottles of Meiji MEIN per day (morning, noon, and evening, or as needed) orally. The dose should be taken continuously from 14 days prior to the scheduled surgery until the day before the surgery. However, if it is difficult to take the full prescribed dose, the dose may be reduced as needed.

Outcome(s)

• Primary Outcome: Change rate of preoperative PNI

Secondary Outcome

1. Preoperative nutritional and metabolic indices (NLR, CAR, GPS, BMI, muscle mass, etc.) and change rate
2. Postoperative outcomes (duration of postoperative thoracic drainage, postoperative complication
rate, postoperative hospital stay, 1-year recurrence-free survival, and overall survival)
3. Changes in tumor microenvironment and microbiome including gut microbiota in preoperative biopsy and surgical resection specimens
4. Status of drug use and symptoms associated with drug use

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. The subject has received a full explanation of the contents of the study and has given written consent.
2. Age at the time of consent: 18 years or older
3. Anatomical surgical resection (segmentectomy or lobectomy) for lung cancer or suspected lung cancer is planned.
4. One or more of the following a) to c) are met
a) Patient has low pulmonary function (FEV1.0% <70%) or interstitial shadows on imaging.
b) Patient has undergone preoperative treatment for lung cancer
c) Patient has findings suggestive of malnutrition (BMI < 20 kg/m2 or Alb < 3.5 g/dL).

Exclude criteria

1. Patients with diabetes requiring drug therapy or HbA1c of 6.5% or higher
2. Abnormal liver function (AST [GOT]or ALT [GPT] more than twice the institutional standard)
3. Abnormal renal function (eGFR < 40 mL/min/1.73 m2)
4. Obesity (BMI > 25 kg/m2)
5. History of allergy to milk or soy
6. Taking other nutritional supplements for caloriereplacement
7. Pregnant or lactating woman, positive pregnancy test, or no intention to use contraception
8. Other patients who are deemed inappropriate for this study by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Shien Kazuhiko