Actively Recruiting
Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment
Led by AUSL Romagna Rimini · Updated on 2023-05-31
40
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
A
AUSL Romagna Rimini
Lead Sponsor
F
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an interventional, non-pharmacologic, randomized controlled study evaluating the impact on quality of life of a personalized exercise program in oncogene addicted lung cancer patients undergoing active treatment. Patients will be randomized 1:1 in two arms: arm A (interventional) and arm B (control). The program of physical activity will be established after a test done at the local clinical center and based on easy exercises already studied in other diseases (e.g. coronary syndrome or organ transplant). A smartphone application will allow patients to register their daily physical activity and to easily recover data on strength and endurance. Patients in Arm A will have a home-based physical activity prescription and will be supervised at weeks: 4, 6, 8, 10, 12 by the oncologist and an exercise expert of the local sport center through three exercises (body composition test, endurance test and strength test) and questionnaires. Home-based activity will be monitored daily though a specific application (provided by Technogym). Patients in Arm B will receive an exercise counselling without a subsequent supervision. The three tests and questionnaires will be repeated once a month for three months at the local sport center and oncology center. Counselling will include general information on exercise. Patients will undergo blood sampling at baseline, week 4 and week 12 in order to evaluate changes in their immunological state (lymphocyte populations and cytokines).
CONDITIONS
Official Title
Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willingness to provide written informed consent
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Body mass index greater than 18
- Diagnosis of oncogene-addicted (EGFR, ALK, ROS1, RET, BRAF) stage IV or IIIb non-small cell lung cancer not suitable for local treatment
- Receiving first- or second-line systemic treatment (palliative radiotherapy and prior chemotherapy allowed)
- Patients currently undergoing treatment in clinical trials are excluded
You will not qualify if you...
- Unable to walk
- Immobility for more than 3 days before study enrollment
- Untreated symptomatic brain metastases (non-irradiated or non-resected)
- Severe cardiac impairment (e.g., New York Heart Association (NYHA) class greater than III, recent myocardial infarction within 3 months, severe arrhythmias, high-grade aortic stenosis)
- Severe respiratory failure
- Uncontrolled pain
- Bone metastasis causing increased risk of fractures
AI-Screening
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Trial Site Locations
Total: 1 location
1
S.Maria delle Croci Hospital, Oncology Unit
Ravenna, Italy
Actively Recruiting
Research Team
C
Chiara Bennati, MD
CONTACT
M
Michela Spreafico
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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