POSITIVE – Study (PART III)

In cooperation with the Department of Oncology of Thoracic Tumors, Thoraxklinik-Heidelberg at Heidelberg University Hospital.

The POSITIVE Study (Part III) is a randomized-controlled phase III trial in patients with stage IIIB/IV non-small cell lung cancer (NSCLC). The aim is to evaluate the effects of a 12-/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 partly supervised (in- and outpatient) and partly home-based endurance and resistance training improves quality of life 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.
Our 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.
We hypothesize that patients randomized in the EIP group will show improved QoL and reduced fatigue, as well as improved physical functioning and increased tumor specific immune responses.

Current status
The enrollment for the POSITIVE study (Part III) has been completed in December 2016 with 232 patients.

Christina Diepold
Phone: +49 6221 3968220
E-mail: christina.diepold@nct-heidelberg.de

ClinicalTrials.gov registration: NCT02055508
http://www.clinicaltrials.gov/ct2/show/NCT02055508