LUCAS-PEN: Lung Cancer Surgery in Sarcopenia Patients With Old Age

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05346185

Collaborator

(none)

400

Enrollment

Location

86.6

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The presence of sarcopenia before lung resection surgery might be an important factor of short-term and long-term prognosis in lung cancer patients. Through this study, investigators plan to demonstrate evidence whether sarcopenia is a useful clinical biomarker for risk stratification in elderly patients undergoing lung cancer surgery.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia Lung Cancer

Detailed Description

Sarcopenia is a syndrome characterized by a decrease in the amount and function of skeletal muscle, and is known to have a prevalence of about 6-10% in 65 years of age or older and about 20-25% in 70 years of age or older. Recently, many studies have been conducted on the clinical importance of sarcopenia, and it has been reported that sarcopenia is significantly associated with a decline in quality of life and physical activity in the elderly population, as well as harmful clinical outcomes in postoperative patients and poor long-term outcomes in various solid cancer patients. Due to the promising result of lung cancer screening trial, lung cancer has been included in national cancer screening in South Korea since last year. As a result, more people are being diagnosed with lung cancer early. Furthermore, the number of patients having surgical resection for lung cancer is steadily growing, and as life expectancy rises, even older patients are increasingly considering surgical treatment. It's critical to appropriately assess risk in older individuals before and after surgery, and sarcopenia is considered a significant fartor for major surgery. According to studies on the association between sarcopenia and the postoperative clinical outcome of lung cancer surgery, sarcopenia evaluated by computed tomography has demonstrated to be associated with a poor surgical outcome and long-term prognosis. However, according to two recognized guidelines for sarcopenia (European Working Group on Sarcopenia in Elder People, and Asian Working Group for Sarcopenia), sarcopenia is supposed to comprehensively evaluate muscle mass, muscle strength, and physical activity. Regarding muscle mass, it is recommended to measure through dual energy-ray absoptiometery or bioelectrial impedance analysis. However, so far, there are no studies that have conducted an accurate evaluation of sarcopenia in elderly lung cancer patients and analyzed the relationship between them and the clinical outcome after lung cancer surgery.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Association of Preoperative Sarcopenia on Postoperative Outcomes After Lung Cancer Surgery: Prospective Observational Study

Actual Study Start Date :

Apr 13, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2028

Outcome Measures

Primary Outcome Measures

overall survival [5 years after the day of lung cancer surgery]
survival status during the follow-up after the lung cancer surgery

Secondary Outcome Measures

recurrence free survival [up to 5 years after the day of lung cancer surgery]
any recurrence or death during the follow-up after the lung cancer surgery
non-cancer related mortality [up to 5 years after the day of lung cancer surgery]
any death not related to lung cancer during the follow-up after the lung cancer surgery
postoperative change of pulmonary function [at postoperative 1 year, 5 year]
pulmonary function during the follow-up after the lung cancer surgery
postoperative complication rate [from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)]
complication after lung cancer surgery
operative mortality [from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)]
mortality related to lung cancer surgery
length of stays [from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)]
length of hospital stays after lung cancer surgery
quality of life questionnaire [before the surgery, at postoperative 1 year, and at postoperative 5 year]
EQ-5D-5L (5-level European quality of life Five Dimension)
quality of life questionnaire [before the surgery, at postoperative 1 year, and at postoperative 5 year]
EQ-VAS (European quality of life visual analogue score)
geriatric depression scale questionnaire [before the surgery, at postoperative 1 year, and at postoperative 5 year]
Korean version geriatric depression scale (0-15, higher number indicates normal mood)
cognitive function questionnaire [before the surgery, and at postoperative 5 year]
Korean version Montreal Cognitive Assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients planning to perform curative surgery for confirmed lung cancer and pulmonary nodules suspected for lung cancer
Patients or legal representatives who could understand and write written consent prior to the initiation of the clinical trial and are able to comply with the requirements for the clinical trial

Exclusion Criteria:

Patients with treatment history for lung cancer or other solid cancer within 5 years (except patients with adenocarcinoma in situ for lung cancer)
Patients who need simultaneous surgery with lung caner surgery for other accompanying diseases
Patients who are not eligible to participate in the study judged by the researcher