Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment

Summary

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).

Eligibility

Inclusion Criteria:

1. Age 18 years or older
2. Willingness to provide written informed consent.
3. Life expectancy \>12 weeks.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
5. Body massa index \> 18.
6. Oncogene-addicted (EGFR, ALK, ROS1, RET, BRAF) stage IV or III b not suitable for local treatment receiving first- or second-line systemic treatment (palliative radiotherapy and prior chemotherapy allowed). Patients undergoing treatment in clinical trials are excluded.

Exclusion Criteria:

1. Inability to walk.
2. Immobility for more than 3 days before study enrollment.
3. Previously untreated (non-irradiated or non-resected) symptomatic brain metastases.
4. Severe cardiac impairment (e.g. cardiac insufficiency New York Heart Association (NYHA) \> III, myocardial infarction within the last three months, severe cardiac arrhythmias, high grade aortic stenosis).
5. Severe respiratory failure.
6. Uncontrolled pain.
7. Bone metastasis inducing increased risk of pathological fractures.

Conditions3

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