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Clinical Trials/NCT07543601
NCT07543601
Recruiting
Not Applicable

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

Ditte Krag-Hansen1 site in 1 country280 target enrollmentStarted: March 6, 2026Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Ditte Krag-Hansen
Enrollment
280
Locations
1
Primary Endpoint
CAT score

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Usual care

No Intervention

Lung cancer investigation only

Tailored COPD consultation

Experimental

Tailored COPD 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

Intervention: Tailored COPD consultations (Other)

Outcomes

Primary Outcomes

CAT score

Time Frame: Baseline, after 3 months and after 6 months

CAT consists of a questionnaire with eight items with the possibility of scoring 0-40 on respiratory symptoms. Participants will be tested at baseline, and after a follow-up period of 3 and 6 months after enrollment of the study.

Secondary Outcomes

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

Investigators

Sponsor
Ditte Krag-Hansen
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ditte Krag-Hansen

Principal Investigator

Region of Southern Denmark

Study Sites (1)

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