Non-small Cell Lung Cancer (NSCLC)NCT07159646
Athletic Intervention After THoracic surgEry for luNg cAncer: a Pilot Study
A study testing exercise interventions in people with Non-small Cell Lung Cancer (NSCLC), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
This is a pilot trial, monocentric interventional study that aims to investigate the results obtained by administering a specific athletic/physical protocol to a cohort of patients who undergo lung surgery after Non-small cell lung cancer (NSCLC) diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- exercise interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male and female ≥18 years old
- Patient underwent a curative surgical treatment of NSCLC (stage IA according to AIOM guidelines, website https://www.iss.it/documents/20126/8403839/LG149_Polmone_agg2024.pdf/9e22916b-799c-3966-7dc9-01762112ce94?version=1.0\&t=1732534604319)
- First whole body CT scan after surgery (executed according to routine procedures two months after surgery) negative for cancer recurrence
- Patients highest scores of performance status, defined after multidisciplinary evaluation by Interdisciplinary Group for Tho-racic Neoplasms (GINT) using ECOG Performance Status Scale and Charlson Comorbidity Index (CCI). Subject with ECOG score 0 and CCI score from 1 to 4 is eligible.
- Informed Consent as documented by signa-ture
Who cannot join
- Requirement of adjuvant treatment
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study,
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the en-tire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. (Female participants who are surgically sterilised/hysterectomised or post- meno-pausal for longer than 2 years are not considered as being of child bearing potential)
- Other clinically significant concomitant disease states (e.g., respiratory failure, COPD, interstitial lung disease, hepatic dysfunction, cardiovascular disease)
- Known or suspected non-compliance, drug or alcohol abuse,
Show all 9Show fewer
- Inability to follow the procedures of the study
- Participation in another study with investigational asset within the 30 days preceding and during the present study
- Enrolment of the investigator, his/her family members, em-ployees and other dependent persons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
Giulia Maria Stella, G.Stella@smatteo.pv.it
About this study
Official title: Athletic Intervention After THoracic surgEry for luNg cAncer: a Pilot Study.
This is a pilot trial, monocentric interventional study that aims to investigate the results obtained by administering a specific athletic/physical protocol to a cohort of patients who undergo lung surgery after Non-small cell lung cancer (NSCLC) diagnosis.
Several studies explored the effects of combined aerobic and resistance training and demonstrated that exercise training improved fitness level (distance walked on the six-minute walk test) and which may also positively influence long-term HRQoL, fatigue, and exercise capacity. Due to the limited number of studies, the effect of exercise training on improvement of pulmonary function (FEV1 and DLCO) and quality of life and other outcomes is still unclear.
Read more
Several studies explored the effects of combined aerobic and resistance training, however few and controversial data are till now available regarding athletic programs for NSCLC resected patients with good performance status.
Ten consecutive patients who underwent resective surgery for NSCLC (5 males and 5 females) will be recruited in to the study.
Before and after the training program, patients will undergo evaluation procedures aimed at investigating exercise capacity, respiratory capacity and muscle power. Both the evaluations and exercise sessions will take place at the CRIAMS Sports Medicine Centre (University of Pavia).
Each patient will be addressed to a 6-month athletic program under the supervision of a motor scientist to evaluate if this active intervention could positively impact on the recovery and improvement of pulmonary function as well as on quality of life after surgery for cancer.
The primary endpoint will be the change of pulmonary function VO2 max) measured at baseline and at the 6 th month of the study. It is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min.
Study findings will be compared to storage data on NSCLC patients (with comparable features) who underwent surgery in absence of subsequent active training programs.
Read the detailed description
The aim of this pilot study is to assess in a preliminary cohort the effect of an active athletic training program in improving respiratory function parameters as well as quality of life after resective surgery for lung cancer. Ten patients (5 males and 5 females) who underwent lung resection for cancer will be identified and selected based on their high PS, the absence of comorbidity and need of adjuvant therapy based on post operative TNM disease stage IA and after multidisciplinary evaluation by GINT. The study will last 6 months for each of the 10 subjects enrolled during 12 months. The subsequent follow up for each patient will last 6 months. Each patient will be addressed to a 6-month athletic program under the supervision of a motor scientist to evaluate if this active intervention could positively impact on the recovery and improvement of pulmonary function as well as on quality of life after surgery for cancer. Moreover, although a pilot study, we will also evaluate stratify patients based on their gender and age to evaluate potential impact of demographic features.
Study participants will be recruited at Fondazione IRCCS Policlinico San Matteo, SC Pneumologia among those patients affected by lung cancer and addressed to surgery with a curative setting. After surgery each case will be rediscussed multidisciplinary and patients with higher performance status, defined by ECOG score 0 and CCI score from 1 to 4, will be selected for the study.
Specifically the ECOG Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. An ECOG score of 0 identifies a fully active person, able to perform all pre-disease services without limitations. The Charlson Comorbidity Index (CCI) is used to classify comorbid conditions which may influence mortality risk. The severity of comorbidity from mild (CCI scores of 1-2) to moderate (CCI scores of 3-4) is used for the selection of patients in the study. Higher scores indicate a more severe condition and consequently, a worse prognosis.
Data obtained will be compared to storage data and published ones on patients with the same features of those enrolled in the study, who are addressed on to follow up after surgery.
Patients will be followed by motor scientists during their active training. Exercises could be slightly modified and each modification will be reported to CRF. In case of need of relevant modification of the training exercises the patient will leave the study.
The patient will enter the study 30 days after surgery. The first screening visit will encompass spirometry, DLCO analysis and VO2 max calculation. Patients will also undergo electrocardiogram (ECG) as per clinical practice, standard routine blood exam and clinical visit. Then the patient will enter the trial and subsequent controls, similar to the first one will be done at 3rd and 6th month, at the end of the program. At the same intervals a total body CT scan will be performed, as per clinical practice. After the end of the active interventional study, patients will continue the standard follow up procedures according to national and international guidelines.
The primary endpoint will be the change of pulmonary function VO2 max) measured at baseline and at the 6 th month of the study. It is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min.
Secondary endpoint will be:
- the change of pulmonary function (FEV1 and DLCO and VO2 max) measured at baseline, at the 3 rd and at the 6 th month of the study. The latter is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min.
- The quality of life will be assessed by the EORTC QLQ-C30 (vers. 3) Questionnaire a 30-item instrument designed to measure quality of life in all cancer patients [21].
- Improvement in caloric consumption measured by metabolic equivalents (MET).
Although being a pilot study, demographic exploratory outcomes would be assessed. Results will be analysed to evaluate if observed differences in outcomes could be related to gender and/or age of the subjects since it is conceivable that the two variables could affect athletic performances and primary and secondary outcomes.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- exercise interventions
- Keywords
- NSCLC, athletic protocol, pulmonary function, HRQoL
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionsOther
athletic/physical protocol
| Study group | Role | What they receive |
|---|---|---|
| athletic programs for NSCLC resected patients with good performance status | Experimental | evaluation procedures aimed at investigating exercise capacity, respiratory capacity and muscle power Receives: Other: exercise interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints will be improvement of pulmonary function (VO2max)
The primary endpoint will be the change of pulmonary function (VO2 max) measured at baseline and at the 6 th month of the study. It is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min
Measured: From enrollment to the 6 th month of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Low risk, inactive non-invasive devices
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Principal investigator, Giulia Maria Stella, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Angelo Guido Corsico, MD,, Study director, Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159646
- Sponsor's protocol ID
- ATHENA study
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Omiya K, Itoh H, Osada N, Kato M, Koike A, Sagara K, Aoki K, Fu LT, Watanabe H, Kato K, Tanabe K, Murayama M. Impaired heart rate response during incremental exercise in patients with acute myocardial infarction and after coronary artery bypass grafting: evaluation of coefficients with Karvonen's formula. Jpn Circ J. 2000 Nov;64(11):851-5. doi: 10.1253/jcj.64.851.
PubMed 11110430Hinz A, Weis J, Faller H, Brahler E, Harter M, Keller M, Schulz H, Wegscheider K, Koch U, Geue K, Gotze H, Mehnert A. Quality of life in cancer patients-a comparison of inpatient, outpatient, and rehabilitation settings. Support Care Cancer. 2018 Oct;26(10):3533-3541. doi: 10.1007/s00520-018-4211-4. Epub 2018 Apr 26.
PubMed 29700655Saito H, Hatakeyama K, Konno H, Matsunaga T, Shimada Y, Minamiya Y. Impact of pulmonary rehabilitation on postoperative complications in patients with lung cancer and chronic obstructive pulmonary disease. Thorac Cancer. 2017 Sep;8(5):451-460. doi: 10.1111/1759-7714.12466. Epub 2017 Jul 11.
PubMed 28696575Voorn MJJ, Driessen EJM, Reinders RJEF, van Kampen-van den Boogaart VEM, Bongers BC, Janssen-Heijnen MLG. Effects of exercise prehabilitation and/or rehabilitation on health-related quality of life and fatigue in patients with non-small cell lung cancer undergoing surgery: A systematic review. Eur J Surg Oncol. 2023 Oct;49(10):106909. doi: 10.1016/j.ejso.2023.04.008. Epub 2023 May 2.
PubMed 37301638Yanagita Y, Arizono S, Tawara Y, Oomagari M, Machiguchi H, Tanahashi M, Katagiri N, Iida Y, Kozu R. Physical activity in patients with non-small cell lung cancer after lung resection. Clin Biomech (Bristol). 2024 May;115:106249. doi: 10.1016/j.clinbiomech.2024.106249. Epub 2024 Apr 13.
PubMed 38615547Huang CY, Hsieh MS, Hsieh PC, Wu YK, Yang MC, Huang SY, Tzeng IS, Lan CC. Pulmonary rehabilitation improves exercise capacity, health-related quality of life, and cardiopulmonary function in patients with non-small cell lung cancer. BMC Cancer. 2024 Feb 15;24(1):211. doi: 10.1186/s12885-024-11977-5.
PubMed 38360680Luo N, Dai F, Wang X, Hu B, Zhang L, Zhao K. Pulmonary Rehabilitation Exercises Effectively Improve Chronic Cough After Surgery for Non-small Cell Lung Cancer. Cancer Control. 2024 Jan-Dec;31:10732748241255824. doi: 10.1177/10732748241255824.
PubMed 38764164Ten Cate DWG, van den Berg R, Scholten-Bakker M, Molenaar CJL, von Meyenfeldt EM, Slooter GD, van den Broek FJC, Marres GMH. Multimodal prehabilitation in patients with non-small cell lung cancer: a feasibility study. J Thorac Dis. 2024 May 31;16(5):2776-2789. doi: 10.21037/jtd-23-1929. Epub 2024 May 10.
PubMed 38883662Balduyck B, Hendriks J, Lauwers P, Van Schil P. Quality of life evolution after surgery for primary or secondary spontaneous pneumothorax: a prospective study comparing different surgical techniques. Interact Cardiovasc Thorac Surg. 2008 Feb;7(1):45-9. doi: 10.1510/icvts.2007.159939. Epub 2007 Aug 17.
PubMed 17704125Zawadzka-Fabijan A, Fabijan A, Lochowski M, Pryt L, Polis B, Zakrzewski K, Kujawa JE, Kozak J. Functional and Disability Outcomes in NSCLC Patients Post-Lobectomy Undergoing Pulmonary Rehabilitation: A Biopsychosocial Approach. Cancers (Basel). 2024 Jun 20;16(12):2281. doi: 10.3390/cancers16122281.
PubMed 38927985Fevrier E, Yip R, Becker BJ, Taioli E, Yankelevitz DF, Flores R, Henschke CI, Schwartz RM; IELCART Investigators. Change in quality of life of stage IA lung cancer patients after sublobar resection and lobectomy. J Thorac Dis. 2020 Jul;12(7):3488-3499. doi: 10.21037/jtd-20-402.
PubMed 32802427Balduyck B, Hendriks J, Lauwers P, Van Schil P. Quality of life evolution after lung cancer surgery: a prospective study in 100 patients. Lung Cancer. 2007 Jun;56(3):423-31. doi: 10.1016/j.lungcan.2007.01.013. Epub 2007 Feb 16.
PubMed 17306905
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Athletic Intervention After THoracic surgEry for luNg cAncer: a Pilot Study.
- ClinicalTrials.gov ID
- NCT07159646
- Acronym / sponsor ID
- ATHENA study
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- NSCLC, athletic protocol, pulmonary function, HRQoL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- Oct 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Sep 2025 (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 a pilot trial, monocentric interventional study that aims to investigate the results obtained by administering a specific athletic/physical protocol to a cohort of patients who undergo lung surgery after Non-small cell lung cancer (NSCLC) diagnosis.
Several studies explored the effects of combined aerobic and resistance training and demonstrated that exercise training improved fitness level (distance walked on the six-minute walk test) and which may also positively influence long-term HRQoL, fatigue, and exercise capacity. Due to the limited number of studies, the effect of exercise training on improvement of pulmonary function (FEV1 and DLCO) and quality of life and other outcomes is still unclear.
Several studies explored the effects of combined aerobic and resistance training, however few and controversial data are till now available regarding athletic programs for NSCLC resected patients with good performance status.
Ten consecutive patients who underwent resective surgery for NSCLC (5 males and 5 females) will be recruited in to the study.
Before and after the training program, patients will undergo evaluation procedures aimed at investigating exercise capacity, respiratory capacity and muscle power. Both the evaluations and exercise sessions will take place at the CRIAMS Sports Medicine Centre (University of Pavia).
Each patient will be addressed to a 6-month athletic program under the supervision of a motor scientist to evaluate if this active intervention could positively impact on the recovery and improvement of pulmonary function as well as on quality of life after surgery for cancer.
The primary endpoint will be the change of pulmonary function VO2 max) measured at baseline and at the 6 th month of the study. It is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min.
Study findings will be compared to storage data on NSCLC patients (with comparable features) who underwent surgery in absence of subsequent active training programs.
Detailed description
The aim of this pilot study is to assess in a preliminary cohort the effect of an active athletic training program in improving respiratory function parameters as well as quality of life after resective surgery for lung cancer. Ten patients (5 males and 5 females) who underwent lung resection for cancer will be identified and selected based on their high PS, the absence of comorbidity and need of adjuvant therapy based on post operative TNM disease stage IA and after multidisciplinary evaluation by GINT. The study will last 6 months for each of the 10 subjects enrolled during 12 months. The subsequent follow up for each patient will last 6 months. Each patient will be addressed to a 6-month athletic program under the supervision of a motor scientist to evaluate if this active intervention could positively impact on the recovery and improvement of pulmonary function as well as on quality of life after surgery for cancer. Moreover, although a pilot study, we will also evaluate stratify patients based on their gender and age to evaluate potential impact of demographic features.
Study participants will be recruited at Fondazione IRCCS Policlinico San Matteo, SC Pneumologia among those patients affected by lung cancer and addressed to surgery with a curative setting. After surgery each case will be rediscussed multidisciplinary and patients with higher performance status, defined by ECOG score 0 and CCI score from 1 to 4, will be selected for the study.
Specifically the ECOG Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. An ECOG score of 0 identifies a fully active person, able to perform all pre-disease services without limitations. The Charlson Comorbidity Index (CCI) is used to classify comorbid conditions which may influence mortality risk. The severity of comorbidity from mild (CCI scores of 1-2) to moderate (CCI scores of 3-4) is used for the selection of patients in the study. Higher scores indicate a more severe condition and consequently, a worse prognosis.
Data obtained will be compared to storage data and published ones on patients with the same features of those enrolled in the study, who are addressed on to follow up after surgery.
Patients will be followed by motor scientists during their active training. Exercises could be slightly modified and each modification will be reported to CRF. In case of need of relevant modification of the training exercises the patient will leave the study.
The patient will enter the study 30 days after surgery. The first screening visit will encompass spirometry, DLCO analysis and VO2 max calculation. Patients will also undergo electrocardiogram (ECG) as per clinical practice, standard routine blood exam and clinical visit. Then the patient will enter the trial and subsequent controls, similar to the first one will be done at 3rd and 6th month, at the end of the program. At the same intervals a total body CT scan will be performed, as per clinical practice. After the end of the active interventional study, patients will continue the standard follow up procedures according to national and international guidelines.
The primary endpoint will be the change of pulmonary function VO2 max) measured at baseline and at the 6 th month of the study. It is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min.
Secondary endpoint will be:
- the change of pulmonary function (FEV1 and DLCO and VO2 max) measured at baseline, at the 3 rd and at the 6 th month of the study. The latter is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min.
- The quality of life will be assessed by the EORTC QLQ-C30 (vers. 3) Questionnaire a 30-item instrument designed to measure quality of life in all cancer patients [21].
- Improvement in caloric consumption measured by metabolic equivalents (MET).
Although being a pilot study, demographic exploratory outcomes would be assessed. Results will be analysed to evaluate if observed differences in outcomes could be related to gender and/or age of the subjects since it is conceivable that the two variables could affect athletic performances and primary and secondary outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Low risk, inactive non-invasive devices
| Arm | Type | Receives |
|---|---|---|
| athletic programs for NSCLC resected patients with good performance status | Experimental | Other: exercise interventionsevaluation procedures aimed at investigating exercise capacity, respiratory capacity and muscle power |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female ≥18 years old
- Patient underwent a curative surgical treatment of NSCLC (stage IA according to AIOM guidelines, website https://www.iss.it/documents/20126/8403839/LG149_Polmone_agg2024.pdf/9e22916b-799c-3966-7dc9-01762112ce94?version=1.0\&t=1732534604319)
- First whole body CT scan after surgery (executed according to routine procedures two months after surgery) negative for cancer recurrence
- Patients highest scores of performance status, defined after multidisciplinary evaluation by Interdisciplinary Group for Tho-racic Neoplasms (GINT) using ECOG Performance Status Scale and Charlson Comorbidity Index (CCI). Subject with ECOG score 0 and CCI score from 1 to 4 is eligible.
- Informed Consent as documented by signa-ture
Key exclusion criteria (9 listed)
- Requirement of adjuvant treatment
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study,
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the en-tire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. (Female participants who are surgically sterilised/hysterectomised or post- meno-pausal for longer than 2 years are not considered as being of child bearing potential)
- Other clinically significant concomitant disease states (e.g., respiratory failure, COPD, interstitial lung disease, hepatic dysfunction, cardiovascular disease)
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 |
|---|---|---|
| exercise interventionsathletic/physical protocol | Other | athletic programs for NSCLC resected patients with good performance status |
Primary outcome
Primary endpoints will be improvement of pulmonary function (VO2max)
Time frame: From enrollment to the 6 th month of the study
The primary endpoint will be the change of pulmonary function (VO2 max) measured at baseline and at the 6 th month of the study. It is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 11110430Omiya K, Itoh H, Osada N, Kato M, Koike A, Sagara K, Aoki K, Fu LT, Watanabe H, Kato K, Tanabe K, Murayama M. Impaired heart rate response during incremental exercise in patients with acute myocardial infarction and after coronary artery bypass grafting: evaluation of coefficients with Karvonen's formula. Jpn Circ J. 2000 Nov;64(11):851-5. doi: 10.1253/jcj.64.851.
- Results publication: PubMed 29700655Hinz A, Weis J, Faller H, Brahler E, Harter M, Keller M, Schulz H, Wegscheider K, Koch U, Geue K, Gotze H, Mehnert A. Quality of life in cancer patients-a comparison of inpatient, outpatient, and rehabilitation settings. Support Care Cancer. 2018 Oct;26(10):3533-3541. doi: 10.1007/s00520-018-4211-4. Epub 2018 Apr 26.
- Results publication: PubMed 28696575Saito H, Hatakeyama K, Konno H, Matsunaga T, Shimada Y, Minamiya Y. Impact of pulmonary rehabilitation on postoperative complications in patients with lung cancer and chronic obstructive pulmonary disease. Thorac Cancer. 2017 Sep;8(5):451-460. doi: 10.1111/1759-7714.12466. Epub 2017 Jul 11.
- Results publication: PubMed 37301638Voorn MJJ, Driessen EJM, Reinders RJEF, van Kampen-van den Boogaart VEM, Bongers BC, Janssen-Heijnen MLG. Effects of exercise prehabilitation and/or rehabilitation on health-related quality of life and fatigue in patients with non-small cell lung cancer undergoing surgery: A systematic review. Eur J Surg Oncol. 2023 Oct;49(10):106909. doi: 10.1016/j.ejso.2023.04.008. Epub 2023 May 2.
- Results publication: PubMed 38615547Yanagita Y, Arizono S, Tawara Y, Oomagari M, Machiguchi H, Tanahashi M, Katagiri N, Iida Y, Kozu R. Physical activity in patients with non-small cell lung cancer after lung resection. Clin Biomech (Bristol). 2024 May;115:106249. doi: 10.1016/j.clinbiomech.2024.106249. Epub 2024 Apr 13.
- Results publication: PubMed 38360680Huang CY, Hsieh MS, Hsieh PC, Wu YK, Yang MC, Huang SY, Tzeng IS, Lan CC. Pulmonary rehabilitation improves exercise capacity, health-related quality of life, and cardiopulmonary function in patients with non-small cell lung cancer. BMC Cancer. 2024 Feb 15;24(1):211. doi: 10.1186/s12885-024-11977-5.
- Results publication: PubMed 38764164Luo N, Dai F, Wang X, Hu B, Zhang L, Zhao K. Pulmonary Rehabilitation Exercises Effectively Improve Chronic Cough After Surgery for Non-small Cell Lung Cancer. Cancer Control. 2024 Jan-Dec;31:10732748241255824. doi: 10.1177/10732748241255824.
- Results publication: PubMed 38883662Ten Cate DWG, van den Berg R, Scholten-Bakker M, Molenaar CJL, von Meyenfeldt EM, Slooter GD, van den Broek FJC, Marres GMH. Multimodal prehabilitation in patients with non-small cell lung cancer: a feasibility study. J Thorac Dis. 2024 May 31;16(5):2776-2789. doi: 10.21037/jtd-23-1929. Epub 2024 May 10.
- Results publication: PubMed 17704125Balduyck B, Hendriks J, Lauwers P, Van Schil P. Quality of life evolution after surgery for primary or secondary spontaneous pneumothorax: a prospective study comparing different surgical techniques. Interact Cardiovasc Thorac Surg. 2008 Feb;7(1):45-9. doi: 10.1510/icvts.2007.159939. Epub 2007 Aug 17.
- Results publication: PubMed 38927985Zawadzka-Fabijan A, Fabijan A, Lochowski M, Pryt L, Polis B, Zakrzewski K, Kujawa JE, Kozak J. Functional and Disability Outcomes in NSCLC Patients Post-Lobectomy Undergoing Pulmonary Rehabilitation: A Biopsychosocial Approach. Cancers (Basel). 2024 Jun 20;16(12):2281. doi: 10.3390/cancers16122281.
- Results publication: PubMed 32802427Fevrier E, Yip R, Becker BJ, Taioli E, Yankelevitz DF, Flores R, Henschke CI, Schwartz RM; IELCART Investigators. Change in quality of life of stage IA lung cancer patients after sublobar resection and lobectomy. J Thorac Dis. 2020 Jul;12(7):3488-3499. doi: 10.21037/jtd-20-402.
- Results publication: PubMed 17306905Balduyck B, Hendriks J, Lauwers P, Van Schil P. Quality of life evolution after lung cancer surgery: a prospective study in 100 patients. Lung Cancer. 2007 Jun;56(3):423-31. doi: 10.1016/j.lungcan.2007.01.013. Epub 2007 Feb 16.
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CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
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.
Angelo Guido Corsico, MD, study director
Fondazione IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise interventions in people with Non-small Cell Lung Cancer (NSCLC), run by Fondazione IRCCS Policlinico San Matteo di Pavia 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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulia Maria Stella, MD, Principal Investigator (00390382503369, g.stella@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints will be improvement of pulmonary function (VO2max) (time frame: From enrollment to the 6 th month of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07159646, which also lists 12 linked publications.
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 8 Sep 2025.