NCT02055508.

Trial name or title	POSITIVE ‐ Physical Exercise Program in Lung Cancer Patients With Non‐operable Disease Undergoing Palliative Treatment
Methods	Randomised controlled trial Setting: inpatient and outpatient, Germany Study duration: 24 weeks
Participants	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 intravenous 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 syncope 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.
Interventions	Control: weekly "care‐management‐phone‐call" (CMPC), performed by an advanced practice nurse (APN). The CMPCs are based on a structured questionnaire, reflecting pain, shortness of breath, disturbed sleep, exhaustion and distress and potentially treatment related side effects (e.g. infections, polyneuropathy, etc.). In case of demanding management of symptoms or complaints (e.g. uncontrolled pain or breathlessness) the treating physician is contacted by the APN to facilitate improvement. Intervention: combined resistance and endurance program consisting of free weight and rubber band training for major upper and lower body muscle groups respectively of cycling/walking on an ergometer/treadmill 3 times a week. Outpatient periods (3 times a week at least two/one supervised training sessions): supervised training sessions in the local outpatient training centre will comprise of resistance exercise on machines and endurance training on an ergometer/treadmill. For non‐supervised training session during the outpatient period, participants will receive an exercise manual for individualised home‐based exercising. In weekly phone calls, the advanced practice nurse will review adherence to the intervention and identify problems.
Outcomes	HRQoL (FACT‐L), general fatigue (Multidimensional Fatigue Inventory), exercise capacity (6MWD), muscle strength (hand‐grip assessed using hand held dynamometry), survival
Starting date	December 2013
Contact information	Joachim Wiskemann: joachim.wiskemann@nct‐heidelberg.de
Notes