Athletic Intervention After THoracic surgEry for luNg cAncer: a Pilot Study

NCT07159646 | Not Yet Recruiting

• 1 other identifier: ATHENA study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

NSCLC; athletic protocol; pulmonary function; HRQoL

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the 6 th month of the study

Study Arms (1)

athletic programs for NSCLC resected patients with good performance status

EXPERIMENTAL

evaluation procedures aimed at investigating exercise capacity, respiratory capacity and muscle power

Other: exercise interventions

Interventions

exercise interventions OTHER

athletic/physical protocol

athletic programs for NSCLC resected patients with good performance status

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Università degli Studi di Pavia: collaborator

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

Location

Related Publications (12)

• 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.

  PMID: 11110430 BACKGROUND

• Hinz 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.

  PMID: 29700655 BACKGROUND

• Saito 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.

  PMID: 28696575 BACKGROUND

• Voorn 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.

  PMID: 37301638 BACKGROUND

• Yanagita 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.

  PMID: 38615547 BACKGROUND

• Huang 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.

  PMID: 38360680 BACKGROUND

• Luo 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.

  PMID: 38764164 BACKGROUND

• Ten 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.

  PMID: 38883662 BACKGROUND

• Balduyck 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.

  PMID: 17704125 BACKGROUND

• Zawadzka-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.

  PMID: 38927985 BACKGROUND

• Fevrier 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.

  PMID: 32802427 BACKGROUND

• Balduyck 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.

  PMID: 17306905 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Angelo Guido Corsico, MD,

  Fondazione IRCCS Policlinico San Matteo

  STUDY DIRECTOR

Central Study Contacts

Giulia Maria Stella, MD, Principal Investigator

CONTACT

00390382503369; g.stella@smatteo.pv.it

Amelia Grosso, Dr, project manager

CONTACT

00390382502611; a.grosso@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Giulia Maria Stella

Model Details: Low risk, inactive non-invasive devices

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

IT (1)