POSITIVE - Study (Part III) Heidelberg

NCT02055508 | Completed DMC

• 1 other identifier: POSITIVE-III-S-326/2013
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced NSCLC; First Line Treatment

Keywords

Exercise; Physical Activity; Palliative Care; Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (2)

• QoL: Physical Well-Being (FACT-L)

  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

  assessed after 12 weeks of enrolement

• General Fatigue (MFI)

  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.

  assessed after 12 weeks of enrolement

Secondary Outcomes (4)

• Physical Performance (endurance and strength capacity)

  assessed every 3 month after enrolement until month 12

• Psychosocial Parameters (e.g. depression, anxiety, demoralization)

  assessed every 3 month after enrolement until month 12

• Overall survival

  for the period of 1 year after enrolement

• progression-free survival

  for the period of 1 year after enrolement

Other Outcomes (2)

• Adverse Events

  baseline until 6 month after enrolement

• Translational Program / Immunology

  baseline, 3 & 6 month after enrolement

Study Arms (2)

Exercise Intervention Program (EIP)

EXPERIMENTAL

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

Care-Management-Phone-Calls (CMPC)

ACTIVE COMPARATOR

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

Interventions

Exercise Intervention BEHAVIORAL

Exercise Intervention Program (EIP)

Care-Management-Phone-Calls OTHER

Care-Management-Phone-Calls (CMPC); Exercise Intervention Program (EIP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NSCLC stage IIIB/IV
• receiving systemic treatment (palliative radiotherapy accepted)
• BMI \> 18
• ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
• signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• German Cancer Research Center: lead
• National Center for Tumor Diseases, Heidelberg: collaborator
• University Hospital Heidelberg: collaborator

Study Sites (1)

Thoracic Oncology Clinic for Thoracic Diseases

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Related Publications (2)

• Titz C, Hummler S, Schmidt ME, Thomas M, Steins M, Wiskemann J. Exercise behavior and physical fitness in patients with advanced lung cancer. Support Care Cancer. 2018 Aug;26(8):2725-2736. doi: 10.1007/s00520-018-4105-5. Epub 2018 Feb 26.

  PMID: 29480444 DERIVED

• 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. 2016 Jul 19;16:499. doi: 10.1186/s12885-016-2561-1.

  PMID: 27430336 DERIVED

MeSH Terms

Conditions

Motor Activity; Lung Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: February 5, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

DE (1)