Non-Small Cell Lung CancerEXcellenTNCT05306652
Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment
A study testing Supervised physical activity and Unsupervised physical activity in people with Non-Small Cell Lung Cancer, run by AUSL Romagna Rimini at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Supervised physical activity and Unsupervised physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 4 Apr 2022to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 1.
- Body massa index > 18.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Michela Spreafico contact
Italy1 site, 1 recruiting
- Recruiting
S.Maria delle Croci Hospital, Oncology Unit
Ravenna
Chiara Bennati, MD, chiara.bennati@auslromagna.it
About this study
Official title: 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).
Read the 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.
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
- Being tested
- Supervised physical activity, Unsupervised physical activity
- Keywords
- NSCLC, Oncogene addiction, physical activity, personalized
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Oncogene Addiction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised physical activityOther
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
Unsupervised physical activityOther
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 group | Role | What they receive |
|---|---|---|
| A - Home based supervised physical exercise | Experimental | patients will have a home-based physical activity prescription Receives: Other: Supervised physical activity |
| B- Unsupervised physical exercise | Active comparator | patients will receive a physical activity counselling, without a real prescription and supervision Receives: Other: Unsupervised physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 12 weeks
Secondary outcomes (7)
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
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Overall survival (OS)
Overall survival (OS), defined as the time from randomization to death from any cause.
Measured: 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
Measured: 12 weeks
impact of personalized exercise on immunity state
T Lymphocytes modulation during physical activity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start4 Apr 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AUSL Romagna Rimini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiara Bennati, Principal investigator, AUSL Romagna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306652
- Sponsor's protocol ID
- EXcellenT
- Acronym
- EXcellenT
- Status last verified
- May 2023
- First submitted
- 22 Feb 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Extended Oncogene Addicted Lung Cancer in Active Treatment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05306652
- Acronym / sponsor ID
- EXcellenT / EXcellenT
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC, Oncogene addiction, physical activity, personalized
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AUSL Romagna RiminiUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Home based supervised physical exercise | Experimental | Other: Supervised physical activitypatients will have a home-based physical activity prescription |
| B- Unsupervised physical exercise | Active comparator | Other: Unsupervised physical activitypatients will receive a physical activity counselling, without a real prescription and supervision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 1.
- Body massa index > 18.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised physical activitypatients 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 | Other | A - Home based supervised physical exercise |
| Unsupervised physical activitypatients 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 | Other | B- Unsupervised physical exercise |
Primary outcome
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 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 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)
7 secondary outcomes
Adherence to prescription
Time frame: 12 weeks
change of functional capacity
Time frame: 12 weeks
change of muscle strength
Time frame: 12 weeks
tolerance to treatment
Time frame: 12 weeks
Overall survival (OS)
Time frame: 24 months
Patient's satisfaction assessed by dedicated questionnaire
Time frame: 12 weeks
impact of personalized exercise on immunity state
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michela Spreafico contact
Chiara Bennati principal investigator
AUSL Romagna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised physical activity and Unsupervised physical activity in people with Non-Small Cell Lung Cancer, run by AUSL Romagna Rimini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiara Bennati, MD (+39 0544 285778, chiara.bennati@auslromagna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.