POSITIVE - Study (Part III) Heidelberg

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.

Conditions

• Advanced NSCLC
• First Line Treatment

Interventions

BEHAVIORAL

Exercise Intervention

OTHER

Care-Management-Phone-Calls

Sponsors & Collaborators

• National Center for Tumor Diseases, Heidelberg

  collaborator OTHER

• University Hospital Heidelberg

  collaborator OTHER

• German Cancer Research Center

  lead OTHER

Principal Investigators

• Michael Thomas, Prof. Dr. · Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg

• Joachim Wiskemann, Dr. · National Center for Tumor Diseases (NCT)

• Simone Hummler, Dr. · Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-31

Primary Completion

2017-03-31

Completion

2018-03-31

Countries

• Germany

Study Locations