Please select the eligibility criteria that correspond to the clinical trial below.
Title: Physical Exercise Program in Lung Cancer Patients With Non-operable Disease Undergoing Palliative Treatment
Brief Summary: The investigators plan to evaluate, in a randomized, controlled phase III trial in patients with advanced non-small cell lung cancer (NSCLC), the effects of a 24-week exercise intervention program (EIP) on quality of life, physical functioning and immune function parameters. Eligible patients (n=250) will be enrolled in the Clinic for Thoracic Diseases, Heidelberg, over a time period of two years and followed up for a total of 12 months.

Patients will be randomized either to EIP plus Care Management Phone Calls (CMPC) versus CMPC alone (besides a proper symptom and side effect management CMPC ensures the potential influence of social contacts that can be anticipated for the patients in the intervention group).

Our primary aims are to investigate whether a combination of a partly supervised (in- and outpatient) and partly home-based endurance and resistance training improves quality of life (QoL) and lowers levels of fatigue (evaluation via the standardized and validated questionnaires FACT-L and MFI). In addition we propose to evaluate the effects of EIP on tumor specific immune responses. Biomarkers of immune function will be measured by cellular immunity and cytokine and chemokine panels.

Further secondary outcomes include measurement of anxiety, depression and demoralization, physical performance parameters (e.g. improvement in walk distance, muscle strength), as well as overall and progression free survival analyses.

The study builds on a previous feasibility study of a 8 weeks exercise intervention trial in patients with advanced NSCLC with the results being utilized in the design of the here proposed trial.

The investigators hypothesize that patients randomized in the exercise intervention group will show improved QoL and reduced fatigue, as well as improved physical functioning and increased tumor specific immune responses.


Options:
A: Inclusion Criteria:

* Histologically diagnosed with lung cancer
* Stage I, II, or III
* Eligible for chemotherapy with curative intent
* 21 years of age or older
* Approval to participate in study by treating oncologist or family physician

Exclusion Criteria:

* Unstable cardiac disease
* Untreated bone or brain metastases
B: Inclusion Criteria:

* Age \>18 years; scheduled for thoracic surgery on the suspicion/confirmed lung tumor via open thoracotomy or Visual Assisted Thoracotomy(includes primary lung cancer, metastases from other cancer sites without activity within none year, other tumor types requiring resection of lung tissue; Furthermore, for RCT, one of the following: Age ≥ 70 years or FEV1 ≤ 70% predicted or DLCO ≤ 70% predicted or scheduled pneumonectomy)

Exclusion Criteria:

* physical or mental deficits that adversely influence physical performance; can neither speak nor read Danish; previous ipsilateral lung resection; tumor activity in other sites or organs; pancoast tumor
C: Inclusion Criteria:

* NSCLC stage IIIB/IV
* receiving systemic treatment (palliative radiotherapy accepted)
* BMI \> 18
* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
* signed informed consent

Exclusion Criteria:

* serious active infection (i.e. requiring an iv antibiotic, antifungal or antiviral agent)
* inability to walk
* immobility (more than two days)
* previously untreated (non-irradiated or non-resected) symptomatic brain metastases;permitted are: (1) previously treated brain metastases \[radiotherapy, surgery, dexamethasone dosage 8 mg per day, anti-epileptic therapy\]; (2) asymptomatic brain metastases without additional therapy requirement
* severe neurologic impairment (e.g. apoplectic insult, Morbus Parkinson, pareses of extremities)
* severe cardiac impairment (e.g. cardiac insufficiency NYHA (New York Heart Association) \> III, myocardial infarction within the last three months, unexplained syncopal events, severe cardiac arrhythmias, high grade aortic stenosis)
* severe respiratory insufficiency
* uncontrolled pain
* abuse of alcohol or drugs reducing compliance to the study
* bone metastasis inducing skeletal fragility
* any circumstance that would impede ability to give informed consent or adherence to study requirements.
D: Inclusion Criteria:

* Palliative cancer patients,
* life expectancy between 3 and 12 months,
* Karnofsky status equally or above 60,
* pain score equal or below 3 on numerical rating scale (0-10),
* cognitive function intact

Answer: C