Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Impact of personalized prescription of physical exercises on quality of life assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for lung cancer (QLQ-LC29)
Study Overview
Brief 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).
Detailed Description
This is an interventional, non pharmacological, randomized controlled trial evaluating the impact on quality of life of a personalized exercise program in oncogene addicted lung cancer patients undergoing active treatment.
At Baseline every patient will receive three tests at the Division of Sport Medicine of Azienda Unità Sanitaria Locale (AUSL) of Romagna (Ravenna)
- Body composition Analysis: Height, Weight, Bioimpedentiometry (resistance and reactance), Volume of Oxygen (VO2) max.
- Endurance test: 1 Km treadmill test.
- Strength test: Repetition of three different exercises (Chest press - upper limbs; Leg press - lower limbs; Lat pull down or Lat Machine or Upper Back).
After the three tests have been performed patients will be evaluated for eligibility and randomized into two arms: Arm A (interventional) and Arm B (control).
The program will be guided (prescribed and supervised) by an oncologist and a sport medicine doctor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Willingness to provide written informed consent.
- •Life expectancy >12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Body massa index >
- •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
- •Inability to walk.
- •Immobility for more than 3 days before study enrollment.
- •Previously untreated (non-irradiated or non-resected) symptomatic brain metastases.
- •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).
- •Severe respiratory failure.
- •Uncontrolled pain.
- •Bone metastasis inducing increased risk of pathological fractures.
Outcomes
Primary Outcomes
Impact of personalized prescription of physical exercises on quality of life assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for lung cancer (QLQ-LC29)
Time Frame: 12 weeks
To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire for lung cancer (QLQ-LC29)
Impact of personalized prescription of physical exercises on quality of life assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Time Frame: 12 weeks
To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Impact of personalized prescription of physical exercises on quality of life assessed by the Beck Depression Inventory II (BDI-II)
Time Frame: 12 weeks
To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of Beck Depression Inventory II (BDI-II)
Secondary Outcomes
- change of muscle strength(12 weeks)
- change of functional capacity(12 weeks)
- tolerance to treatment(12 weeks)
- Adherence to prescription(12 weeks)
- Overall survival (OS)(24 months)
- Patient's satisfaction assessed by dedicated questionnaire(12 weeks)
- impact of personalized exercise on immunity state(12 weeks)