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:

* LVEF less than or equal to 35%
* New York Heart Association (NYHA) class II, III, or IV CHF diagnosis in the 3 months prior to study entry, with a minimum of 6 weeks of treatment
* Must be on optimal heart failure therapy according to American Heart Association (AHA), American College of Cardiology (ACC), and Heart Failure Society of America (HFSA) heart failure guidelines, including treatment with angiotensin II converting enzyme inhibitors (ACEI) and beta-blocker therapy, or have documentation justifying why optimal therapy is not being used, including intolerance, contraindication, participant preference, or physician's judgment
* Must be on stable doses of medications (e.g., beta-blocker, ACEI, and additional medications as listed in the study guidelines) for 6 weeks prior to study entry
* Must be in stable medical condition and able to begin an exercise program, as determined by study physician

Exclusion Criteria:

* Comorbid disease, behavioral limitations, or other limitations that would interfere with exercise training, or would prevent completion of 1 year of exercise training
* Pregnant or planning to become pregnant in the year following study entry
* Major heart event or heart procedure within the 6 weeks prior to study entry
* Heart procedure or hospitalization for any reason planned in the future
* Expecting to receive a heart transplant in the 6 months following study entry
* CHF caused by significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction); if valve replacement has been performed, may not participate for 12 months following the procedure
* CHF caused by congenital heart disease or obstructive cardiomyopathy
* Performance of exercise training at regular intervals (more than once per week) at a moderate to vigorous intensity at any time in the 6 weeks prior to study entry
* Exercise testing results that would prevent safe exercise training, as defined by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines, including abnormal blood pressure response, early ischemic changes, and unexpected life-threatening arrhythmia
* Use of fixed-rate pacemakers, pacemakers with inability to attain target heart rates, or automatic implantable cardioverter defibrillator (AICD) devices with heart rate limits set below the target heart rate for exercise training
* Use of an intracardiac device such as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy pacemaker in the 6 months prior to study entry (must demonstrate stability for 6 weeks post-procedure)
* Primary physician considers placement of an intracardiac device such as an ICD or a cardiac resynchronization therapy pacemaker probable within 6 months of study entry; will be excluded until such device has been placed and 6 weeks of stabilization have passed
* Participation in another clinical trial that may interfere with study participation, follow-up, or data collection, or that may affect cardiovascular morbidity or mortality
B: 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.
C: Inclusion Criteria:

* Women
* Completed chemotherapy within past 2 years

  * completed for at least 3 months
* Self report cognitive dysfunction following chemotherapy
* Stage I-IIIA breast cancer
* Physically able to undertake moderate to vigorous physical activity program

Exclusion Criteria:

* Self report \> 90min/week of moderate physical activity (last 6 months)
* Mini-mental status exam score \< 23
* Co-morbid conditions that may alter cognitive testing results (i.e., a clinically diagnosed major depression, anxiety disorder, or other psychiatric condition, meeting DSM IV criteria)
* History of substance abuse
* Other neurological disorder (i.e., head injury, epilepsy, tumour, neurodegenerative disease)
* Ruled ineligible for MRI scanning (i.e., metal implants)
D: Inclusion Criteria:

- Patients with locally advanced or advanced prostate cancer being treated with androgen deprivation therapy (S-testosterone \< 1.7) for at least 6 months at the time of inclusion

Exclusion Criteria:

* WHO performance level above 1,symptomatic cardiovascular disorders, osteoporosis (T-score below -2.5)

Answer: B