Clinical trial NCT02055508: POSITIVE - Study (Part III) Heidelberg
Official title: Physical Exercise Program in Lung Cancer Patients With Non-operable Disease Undergoing Palliative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced NSCLC
First Line Treatment
Keywords: Exercise
Physical Activity
Palliative Care
Lung Cancer
NSCLC
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: National Center for Tumor Diseases, Heidelberg
name: University Hospital Heidelberg
First posted: 2014-02-05
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: QoL: Physical Well-Being (FACT-L)
timeFrame: assessed after 12 weeks of enrolement
measure: General Fatigue (MFI)
timeFrame: assessed after 12 weeks of enrolement
Secondary outcomes:
measure: Physical Performance (endurance and strength capacity)
timeFrame: assessed every 3 month after enrolement until month 12
measure: Psychosocial Parameters (e.g. depression, anxiety, demoralization)
timeFrame: assessed every 3 month after enrolement until month 12
measure: Overall survival
timeFrame: for the period of 1 year after enrolement
measure: progression-free survival
timeFrame: for the period of 1 year after enrolement
Other outcomes:
measure: Adverse Events
timeFrame: baseline until 6 month after enrolement
measure: Translational Program / Immunology
timeFrame: baseline, 3 & 6 month after enrolement
Locations:
city: Heidelberg
country: Germany
facility: Thoracic Oncology Clinic for Thoracic Diseases
state: Baden-Württemberg
Study officials:
affiliation: Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg
name: Michael Thomas, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Tumor Diseases (NCT)
name: Joachim Wiskemann, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg
name: Simone Hummler, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Titz C, Hummler S, Schmidt ME, Thomas M, Steins M, Wiskemann J. Exercise behavior and physical fitness in patients with advanced lung cancer. Support Care Cancer. 2018 Aug;26(8):2725-2736. doi: 10.1007/s00520-018-4105-5. Epub 2018 Feb 26.
citation: Wiskemann J, Hummler S, Diepold C, Keil M, Abel U, Steindorf K, Beckhove P, Ulrich CM, Steins M, Thomas M. POSITIVE study: physical exercise program in non-operable lung cancer patients undergoing palliative treatment. BMC Cancer. 2016 Jul 19;16:499. doi: 10.1186/s12885-016-2561-1.