Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment (EXcellenT)

Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment: a Randomized Controlled Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Other: Supervised physical activity; Other: Unsupervised physical activity

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chiara Bennati, MD; Phone Number: +39 0544 285778; Email: chiara.bennati@auslromagna.it
• Study Contact Backup: Name: Michela Spreafico; Email: michela.spreafico@irst.emr.it

Study Locations

• Italy
  • Ravenna, Italy
    • Recruiting
    • S.Maria delle Croci Hospital, Oncology Unit
    • Contact: Chiara Bennati, MD; Email: chiara.bennati@auslromagna.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A - Home based supervised physical exercise; patients will have a home-based physical activity prescription	Other: 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
Active Comparator: B- Unsupervised physical exercise; patients will receive a physical activity counselling, without a real prescription and supervision	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	12 weeks
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)	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)	12 weeks
Impact of personalized prescription of physical exercises on quality of life assessed by the Beck Depression Inventory II (BDI-II)	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)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to prescription	To evaluate the adherence to the step-counter and the strength training prescription monitored through a specific smartphone application. the number of weeks (at least 9 out of 12 weeks) a subject follows the personalized activity prescription will be measured	12 weeks
change of functional capacity	Functional capacity will be measured through the 1 Km treadmill test (at baseline; at week 4, week 8 and at week 12): arm A versus arm B. For those in the experimental arm, as the individual progresses with the exercise plan, the exercise dosage will be modulated to facilitate improvements.	12 weeks
change of muscle strength	Muscle strength will be measured through the maximum repetition tests (at baseline; at week 4, week 8 and at week 12): arm A versus arm B. For those in the experimental arm, as the individual progresses with the exercise plan, the exercise dosage will be modulated to facilitate improvements.	12 weeks
tolerance to treatment	Monitoring the frequency, duration, and severity of adverse events (AEs), through physical examinations, changes in vital signs and through clinical laboratory blood.	12 weeks
Overall survival (OS)	Overall survival (OS), defined as the time from randomization to death from any cause.	24 months
Patient's satisfaction assessed by dedicated questionnaire	Patient's satisfaction of an App-based system to guide and monitor home-based physical activity is assessed by dedicated questionnaire addressing specific issues	12 weeks
impact of personalized exercise on immunity state	T Lymphocytes modulation during physical activity	12 weeks

Collaborators and Investigators

• Sponsor: AUSL Romagna Rimini
• Collaborators: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Investigators: Principal Investigator: Chiara Bennati, AUSL Romagna

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; NSCLC; Oncogene addiction; personalized
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: EXCELLENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No