NCT07159646Toborzás még nem indult
Athletic Intervention After THoracic surgEry for luNg cAncer: a Pilot Study
Athletic Intervention After THoracic surgEry for luNg cAncer: a Pilot Study.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 8. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 10 (tervezett)
- Első benyújtás
- 2025. aug. 26.
- Kezdés
- 2025. okt.
- Elsődleges befejezés
- 2027. márc.
- Fő szponzor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Betegségek
- Tüdőrák
- NCT-szám
- NCT07159646
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 10
- 2025. okt. és az elsődleges befejezés (2027. márc.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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,
Egyéb
- 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)
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo di Pavia Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Pavia | Olaszország | Ismeretlen állapot |
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