Lung Cancer Surgery in Sarcopenia Patients With Old Age

Lung Cancer Clinical Trial

— LUCAS-PEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346185
• Other study ID #: 800-20210011
• Status: Recruiting
• Start date: April 13, 2021
• Est. completion date: June 30, 2028

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Kwon Joong Na, MD
• Phone: 82-10-3329-9392
• Email: kjna85[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Sarcopenia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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