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Preoperative Immuno-Nutritional Therapy for Lung Cancer

Preoperative Immuno-Nutritional Therapy for High-Risk Lung Cancer Surgery Patients - PINT-LC

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061240049
Enrollment
40
Registered
2024-09-02
Start date
2025-08-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

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

Sponsors

Shien Kazuhiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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).

Exclusion criteria

Exclusion 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 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.

Design outcomes

Primary

MeasureTime frame
Change rate of preoperative PNI

Secondary

MeasureTime frame
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

Contacts

Public ContactKazuhiko Shien

Okayama University Hospital

k.shien@okayama-u.ac.jp+81-86-235-7265

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026