Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT03223805
Eligibility Criteria:
Inclusion Criteria:
1. A diagnosis of lung cancer - primary tumour, secondary tumour or mesothelioma
2. Suffering from refractory breathlessness or cough or fatigue (presence of a minimum of two of the three symptoms), and which is bothersome to the patient (see below)\*
3. In the presence of COPD, in stable condition
4. WHO Performance Status 0-2
5. Expected prognosis of at least 3 months
6. 18+ years
7. able to give informed consent
* Patients will be asked as part of the symptom screening process:
Are you affected in your day to day life by breathlessness? Are you affected in your day to day life by cough? Are you affected in your day to day life by fatigue?
Exclusion Criteria:
1. Patients who are experiencing breathlessness, cough and/or fatigue but do not find these symptoms bothersome are not eligible (see below)\*
2. Acute exacerbation\*\* of COPD, or chest infection, within the past 3 weeks, necessitating a change in medication
3. Rapidly worsening breathlessness requiring urgent medical intervention
4. Post chemotherapy and/or radiotherapy to the chest \> 2 weeks
5. Surgical treatment for lung cancer \> 4 weeks
* Patients will be asked as part of the symptom screening process:
Are you affected in your day to day life by breathlessness? Are you affected in your day to day life by cough? Are you affected in your day to day life by fatigue?
\*\* An exacerbation is defined as a sustained worsening of the patient's symptoms from their usual stable state which is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication. NICE guidelines 201025. In this trial, patients will only be excluded if a change in medications were required - i.e. steroids or antibiotics.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03223805
Study Brief:
Protocol Section:
NCT03223805