Clinical trial NCT05306652: Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment
Official title: Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Oncogene addiction
physical activity
personalized
Lead sponsor: AUSL Romagna Rimini
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
First posted: 2022-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)

1. Body composition Analysis: Height, Weight, Bioimpedentiometry (resistance and reactance), Volume of Oxygen (VO2) max.
2. Endurance test: 1 Km treadmill test.
3. 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.

Arm A (interventional): patients will have a home-based physical activity prescription, defined on the functional endurance and strength tests and they will be supervised for 3 months. Once monthly they will be examined by the oncologist (visit and questionnaires) and at weeks 4, 6, 8, 10 and 12 at the sport medicine center where the three tests will be repeated. Home-based activity will be monitored daily through a specific application (provided by Technogym). Endurance improvement is defined as an increase in walking speed; strength improvement is defined as an increase of the number of repetitions.

Arm B (control): patients will receive a physical activity counselling, without a real prescription and supervision, and the three test will be repeated once a month for three months at the local sport medicine center and at the oncology center (visit and questionnaires). Counselling will include general informations on physical exercise.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 12 weeks
measure: 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)
timeFrame: 12 weeks
measure: Impact of personalized prescription of physical exercises on quality of life assessed by the Beck Depression Inventory II (BDI-II)
timeFrame: 12 weeks
Secondary outcomes:
measure: Adherence to prescription
timeFrame: 12 weeks
measure: change of functional capacity
timeFrame: 12 weeks
measure: change of muscle strength
timeFrame: 12 weeks
measure: tolerance to treatment
timeFrame: 12 weeks
measure: Overall survival (OS)
timeFrame: 24 months
measure: Patient's satisfaction assessed by dedicated questionnaire
timeFrame: 12 weeks
measure: impact of personalized exercise on immunity state
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ravenna
country: Italy
facility: S.Maria delle Croci Hospital, Oncology Unit
Study officials:
affiliation: AUSL Romagna
name: Chiara Bennati
role: PRINCIPAL_INVESTIGATOR
References: