Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment

NCT ID: NCT05306652

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2026-06-01

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A - Home based supervised physical exercise

patients will have a home-based physical activity prescription

Group Type: EXPERIMENTAL

Supervised physical activity

Intervention Type: OTHER

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. Endurance improvement is defined as an increase in walking speed; strength improvement is defined as an increase of the number of repetitions

B- Unsupervised physical exercise

patients will receive a physical activity counselling, without a real prescription and supervision

Group Type: ACTIVE_COMPARATOR

Unsupervised physical activity

Intervention Type: OTHER

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

Interventions

Supervised physical activity

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. Endurance improvement is defined as an increase in walking speed; strength improvement is defined as an increase of the number of repetitions

Intervention Type: OTHER

Unsupervised physical activity

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: collaborator

AUSL Romagna Rimini

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chiara Bennati

Role: PRINCIPAL_INVESTIGATOR

AUSL Romagna

Locations

S.Maria delle Croci Hospital, Oncology Unit

Ravenna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Chiara Bennati, MD

Role: CONTACT

chiara.bennati@auslromagna.it

+39 0544 285778

Michela Spreafico

Role: CONTACT

michela.spreafico@irst.emr.it

Facility Contacts

Chiara Bennati, MD

Role: primary

chiara.bennati@auslromagna.it

Other Identifiers

EXcellenT

Identifier Type: -

Identifier Source: org_study_id