POSITIVE - Study (Part III) Heidelberg

German Cancer Research Center

Status: Completed

Conditions: Advanced NSCLC; First Line Treatment

Treatments: Other: Care-Management-Phone-Calls; Behavioral: Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02055508

POSITIVE-III-S-326/2013

Details and patient eligibility

About

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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 2 patient groups

Exercise Intervention Program (EIP)

Experimental group

Description:

Inpatient periods: The combined resistance and endurance program consist of free weight and rubber band training for major upper and lower body muscle groups respectively of cycling/walking on an ergometer/treadmill 3x/week. Outpatient periods (3x/week at least two/one supervised training sessions): Supervised training sessions in the local outpatient training center 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 individualized home-based exercising. In weekly phone calls, the advanced practice nurse will review adherence to the intervention and identify problems. Furthermore, the patients will also be asked the same questions as in the CMPC group.

Treatment:

Other: Care-Management-Phone-Calls

Behavioral: Exercise Intervention

Care-Management-Phone-Calls (CMPC)

Active Comparator group

Description:

Patients in this arm will receive a 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.

Treatment:

Other: Care-Management-Phone-Calls