POSITIVE - Study
Physical exercise program in lung cancer patients with non-operable disease undergoing palliative treatment
In cooperation with the Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg.
Investigators
Principal Investigators: Prof. Dr. Michael Thomas, Dr. Simone Hummler, Dr. Joachim Wiskemann
Co-Principal Investigators: PD Dr. Steins, Prof. Dr. Philipp Beckhove, Prof. Dr. Dr. Ulrich Abel, Prof. Dr. Karen Steindorf, Prof. Dr. Cornelia Ulrich
Abstract
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.
The study is supported by the German Cancer Aid.
Current status
Recruitment of the POSITIVE study (Part III) was completed in December 2016 with 232 patients.
Contact
Prof. Dr. Karen Steindorf
phone: +49 6221 42 2351
e-mail: karen.steindorf@nct-heidelberg.de
Registration
Publication
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 16, 499, 2016.