Enhanced COPD Management in Suspected Lung Cancer Patients

Official title

Enhanced COPD Management in Suspected Lung Cancer Patients - Improving Outcomes Through Timely Intervention

Overview

Identifying and treating COPD in patients undergoing lung cancer evaluation is crucial. Early intervention could lead to better management of both diseases, improving health status, reducing healthcare costs, and potentially increasing survival rates. This study aims to assess the impact of early diagnosis and optimal treatment of COPD on clinical outcomes in patients under evaluation for lung cancer. The study will combine information through an open-label RCT at the Lung Cancer Investigation Unit at Lillebaelt Hospital Vejle. The findings could inform clinical practice by emphasizing the importance of integrated care approaches for patients with coexisting COPD and lung cancer, ultimately leading to better health outcomes.

Detailed description

Chronic Obstructive Pulmonary Disease (COPD) and lung cancer frequently coexist due to shared risk factors, most notably smoking, which is the leading cause of both conditions. COPD, characterized by persistent airflow limitation and chronic inflammation of the airways, is a major contributor to morbidity and mortality worldwide. Similarly, lung cancer is one of the most common and deadliest cancers, with a significant overlap in the patient populations affected by COPD. Studies suggest that individuals with COPD are at an increased risk of developing lung cancer, with rates estimated to be four to six times higher than in the general population. This overlap is not merely coincidental but is thought to be influenced by chronic inflammation, oxidative stress, and impaired immune responses in the lungs of patients with COPD, which can promote carcinogenesis.

Despite the frequent coexistence of COPD and lung cancer, patients are usually not investigated for COPD as usual care, therefore, COPD often remains underdiagnosed or is diagnosed late, particularly in patients being evaluated for lung cancer. Delayed diagnosis and untreated COPD can negatively affect a patient's overall prognosis, complicating the management of lung cancer. At the same time, some patients with COPD are incorrectly diagnosed and suboptimal treated resulting in progressive deterioration of health status. Deterioration of health status including lung function is contributed by comorbidities in patients with COPD especially cardiovascular diseases.

Overall, patients with COPD tend to have poorer tolerance to lung cancer treatments, including surgery, chemotherapy, and radiotherapy, due to compromised lung function. In contrast, early detection and optimal management of COPD, including pharmacotherapy, smoking cessation, and pulmonary rehabilitation, may improve lung function, enhance treatment tolerance, and reduce complications during cancer therapy.

Given the high prevalence of both COPD and lung cancer in individuals with a history of smoking, identifying and treating COPD in patients undergoing lung cancer evaluation is crucial. Early intervention could lead to better management of both diseases, improving health status, reducing healthcare costs, and potentially increasing survival rates. This study aims to assess the impact of early diagnosis and optimal treatment of COPD on clinical outcomes in patients under evaluation for lung cancer. Specifically, it will explore how timely COPD management affects cancer treatment tolerability, postoperative recovery, hospitalization rates, and overall survival in this high-risk population. The findings could inform clinical practice by emphasizing the importance of integrated care approaches for patients with coexisting COPD and lung cancer, ultimately leading to better health outcomes.

Aim and objectives To assess the impact of early COPD diagnosis and optimal treatment on health status outcomes in patients undergoing lung cancer work-up and to evaluate the effect of early COPD diagnosis and optimal treatment on COPD-related health status in patients undergoing lung cancer work-up.

Interventions

• Other Tailored COPD consultations
  These consultations will include assessment and treatment according to GOLD guidelines, including: Pharmacological management Smoking cessation support Referral to pulmonary rehabilitation as appropriate Referral for nutritional assessment and optimization when appropriate Referral to cardiovascular evaluation when appropriate Referral to sleep apnea evaluation when appropriate

Primary outcome measures

• CAT score [Time frame: Baseline, after 3 months and after 6 months]

Secondary outcome measures (12)

• Weight [Time frame: Baseline and after 6 months]
• Height [Time frame: Basline]
• BMI [Time frame: Baseline and after 6 months]
• 1 min sit-to-stand-test [Time frame: Baseline and after 6 months]
• The ProKOL questionnaire [Time frame: Baseline, after 3 months and after 6 months]
• The HADS questionnaire [Time frame: Baseline, after 3 months and after 6 months]
• Smoking cessation [Time frame: Baseline, after 3 months and after 6 months]
• Number of exacerbations [Time frame: Baseline, after 3 months and after 6 months]
• Mortality [Time frame: After 3 months and after 6 months]
• Hospitalisations [Time frame: Baseline, after 3 months and after 6 months]
• Incidence of Treatment-Emergent Adverse Events [Time frame: After 3 months and after 6 months]
• Postoperative recovery [Time frame: After 3 months and after 6 months]

Eligibility criteria

Inclusion criteria

• Undergoing diagnostic evaluation for suspected lung cancer
• Spirometry showing obstructive airflow limitation (FEV₁/FVC < 75 % or FEV₁ < 80 %, and no reversibility) at the first outpatient visit at the lung cancer evaluation

Exclusion criteria

• Presence of significant comorbidities that may interfere with diagnostic procedures or spirometry
• Pregnant or breastfeeding women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Denmark · 1 center

• Lung Cancer Investigation Unit, Lillebaelt Hospital Vejle — Vejle

Publications

• Huang CY, Hsieh MS, Hsieh PC, Wu YK, Yang MC, Huang SY, Tzeng IS, Lan CC. Pulmonary rehabilitation improves exercise capacity, health-related quality of life, and cardiopulmonary function in patients with non-small cell lung cancer. BMC Cancer. 2024 Feb 15;24(1):211. doi: 10.1186/s12885-024-11977-5. PMID 38360680
• Vagvolgyi A, Rozgonyi Z, Kerti M, Vadasz P, Varga J. Effectiveness of perioperative pulmonary rehabilitation in thoracic surgery. J Thorac Dis. 2017 Jun;9(6):1584-1591. doi: 10.21037/jtd.2017.05.49. PMID 28740672
• Shin S, Kong S, Kang D, Lee G, Cho JH, Shim YM, Cho J, Kim HK, Park HY. Longitudinal changes in pulmonary function and patient-reported outcomes after lung cancer surgery. Respir Res. 2022 Aug 30;23(1):224. doi: 10.1186/s12931-022-02149-9. PMID 36042472
• Illini O, Valipour A, Gattinger D, Petrovic M, Fabikan H, Hochmair MJ, Zwick RH. Effectiveness of Outpatient Pulmonary Rehabilitation in Patients with Surgically Resected Lung Cancer: A Retrospective Real-World Analysis. Cancers (Basel). 2022 Jul 18;14(14):3479. doi: 10.3390/cancers14143479. PMID 35884540
• Huang CY, Hsieh MS, Wu YK, Hsieh PC, Yang MC, Tzeng IS, Lan CC. Chronic obstructive pulmonary disease assessment test for the measurement of deterioration and recovery of health status of patients undergoing lung surgery. Thorac Cancer. 2022 Feb;13(4):613-623. doi: 10.1111/1759-7714.14306. Epub 2022 Jan 6. PMID 34989126
• Deng D, Peng D, Song Q, Lin L, Liu C, Li T, Zhang P, Zeng Y, Lei S, Chen P. Application of GOLD 2023 Initial Inhalation Therapy Recommendations in COPD patients: a real-world adherence and prognosis analysis. J Glob Health. 2025 Nov 28;15:04324. doi: 10.7189/jogh.15.04324. PMID 41313168
• Zhou R, Qin Y, Hu S, Xu Y, Feng C. Effect of dual bronchodilators plus preoperative rehabilitation in operable LC & chronic obstructive pulmonary disease. Future Oncol. 2024 Dec;20(40):3471-3476. doi: 10.1080/14796694.2024.2430164. Epub 2024 Nov 28. PMID 39607005
• Gottlieb M, Mellemgaard A, Marsaa K, Godtfredsen N. Optimizing COPD treatment in patients with lung- or head and neck cancer does not improve quality of life - a randomized, pilot, clinical trial. Eur Clin Respir J. 2020 Mar 2;7(1):1731277. doi: 10.1080/20018525.2020.1731277. eCollection 2020. PMID 32194927

Identifiers

NCT: NCT07543601 · Journal nr.: 25/71 · Project-ID S-20250091

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗