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POSITIVE - Study (Part III) Heidelberg (POSITIVE)

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ClinicalTrials.gov Identifier: NCT02055508
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
National Center for Tumor Diseases, Heidelberg
University Hospital Heidelberg
Information provided by (Responsible Party):
German Cancer Research Center

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.


Condition or disease Intervention/treatment Phase
Advanced NSCLC First Line Treatment Behavioral: Exercise Intervention Other: Care-Management-Phone-Calls Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Physical Exercise Program in Lung Cancer Patients With Non-operable Disease Undergoing Palliative Treatment
Actual Study Start Date : December 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Intervention Program (EIP)

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.

Behavioral: Exercise Intervention
Other: Care-Management-Phone-Calls
Active Comparator: Care-Management-Phone-Calls (CMPC)
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.
Other: Care-Management-Phone-Calls



Primary Outcome Measures :
  1. QoL: Physical Well-Being (FACT-L) [ Time Frame: assessed after 12 weeks of enrolement ]
    The FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire comprises of 36 items and deter-mines the quality of life in patients with lung cancer. It is separated in the subcategories "physical well-being" (PRIMARY OUTCOME), "emotional well-being", "social well-being", "functional well-being and disease-specific items". It is widely used in clinical studies and was already applied in exercise intervention studies in lung cancer patients

  2. General Fatigue (MFI) [ Time Frame: assessed after 12 weeks of enrolement ]
    The MFI (Multidimensional Fatigue Inventory) questionnaire (20 items) evaluates the extent of chronic fatigue and is divided into the 5 subscales "general fatigue", "physical fatigue", "mental fatigue", "reduced motivation" and "reduced activity". The MFI questionnaire is widely used in oncological studies and an adequate number of comparative samples exists.


Secondary Outcome Measures :
  1. Physical Performance (endurance and strength capacity) [ Time Frame: assessed every 3 month after enrolement until month 12 ]

    6-Minute Walk Test (endurance capacity) The 6 minute walk test is feasible and safe to determine patients physical capacity. Patients are instructed to walk in 6 min. as many meters as possible with oxygen saturation and pulse rate being measured concomitantly.

    Hand-held Dynamometry (isometric strength capacity) The hand-held dynamometry is a standardized instrument to measure muscular strength. In the study 6 major muscle groups of upper and lower extremities will be assessed for their isometric power.


  2. Psychosocial Parameters (e.g. depression, anxiety, demoralization) [ Time Frame: assessed every 3 month after enrolement until month 12 ]

    PHQ(Ultra-Brief Patient Health Questionnaire)-4 :

    The PHQ-4 (Ultra-Brief Patient Health Questionnaire) questionnaire is a short instrument comprising of 4 items to detect the extent of depression and anxiety. It provides sufficient diagnostic accuracy for major depression and can be used as a screening instrument in cancer populations.

    DS (Demoralization Scale) The demoralization scale (DS) is a relatively new developed questionnaire to detect the extent of existential distress in cancer patients. The German version was validated in 2011 and comprises of 24 questions. The results of the validation showed that the concept of demoralization is a useful instrument to describe the different states of existential distress and the individual incapacity to cope effectively with stressful situations.


  3. Overall survival [ Time Frame: for the period of 1 year after enrolement ]
  4. progression-free survival [ Time Frame: for the period of 1 year after enrolement ]

Other Outcome Measures:
  1. Adverse Events [ Time Frame: baseline until 6 month after enrolement ]
    Safety analyses will be based on Adverse Events (AE´s), Severe Adverse Events (SAE´s), and Suspected Unexpected Serious Adverse Reaction (SUSARs) recorded during the study. Of particular interest are AEs, SAEs and SUSARs deemed to be potentially causally related to the endurance and resistance training.

  2. Translational Program / Immunology [ Time Frame: baseline, 3 & 6 month after enrolement ]

    Quantification (Q) of immune cells: Multicolor flow cytometry from cryopreserved Peripheral Blood Mononuclear Cell (PBMC), CD (cluster of differentiation) 4+ and CD 8+ T cells, effector, naïve and activated T cells, regulatory T cells (Treg) and their functional subsets, natural killer cells, B cells, monocytes and monocyte-derived myeloid suppressor cells will be assessed.

    Q. of tumor antigen reactive effector/memory T cells: Will be done by interferon gamma Enzyme Linked Immuno Spot Assays from PBMC using a panel of defined tumor antigens presented by generated autologous dendritic cells as antigen presenting cells and purified T cells as responder cells.

    Detection of tumor reactive Treg: Will be done by established Treg specificity assay based on the increased suppressive activity of specifically activated regulatory T cells.

    Q. of key immune effector molecules: Will be done for app. 14 different cytokines and chemokines from cryopreserved serum samples.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055508


Locations
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Germany
Thoracic Oncology Clinic for Thoracic Diseases
Heidelberg, Baden-Württemberg, Germany, 69126
Sponsors and Collaborators
German Cancer Research Center
National Center for Tumor Diseases, Heidelberg
University Hospital Heidelberg
Investigators
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Principal Investigator: Michael Thomas, Prof. Dr. Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg
Principal Investigator: Joachim Wiskemann, Dr. National Center for Tumor Diseases (NCT)
Principal Investigator: Simone Hummler, Dr. Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT02055508     History of Changes
Other Study ID Numbers: POSITIVE-III-S-326/2013
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Keywords provided by German Cancer Research Center:
Exercise
Physical Activity
Palliative Care
Lung Cancer
NSCLC