Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-10
Brief Title:
Exercise in Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
University Hospital Essen
Organization:
University Hospital Essen
Study Overview
Official Title:
Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BREATH
Brief Summary:
Lung cancer is one of the most common types of cancer in Germany with 56839 new cases and 45072 deaths annually Approximately 70 of patients with non-small cell lung cancer NSCLC are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue tiredness and loss of strength The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance Exercise can have positive effects on symptoms such as shortness of breath fatigue quality of life and physical fitness However there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far
The BREATH-study is a prospective 3-arm randomized controlled trial RCT In total the investigators plan to recruit 104 patients A 211 randomization will be performed with three study groups a control group and two exercise therapy groups strengthendurance exerciseonly endurance exercise One group receives individual endurance training and the other group a combination of individual endurance and strength training Both treatment groups will be treated twice a week for 12 weeks The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group as well as between the two exercise therapy approaches
The primary aim is to investigate the impact of exercise on V02peak Secondarily endpoints aim to investigate changes in physical function patient related outcomes and cardiac function before and after exercise
The BREATH-study is a prospective 3-arm randomized controlled trial RCT In total the investigators plan to recruit 104 patients A 211 randomization will be performed with three study groups a control group and two exercise therapy groups strengthendurance exerciseonly endurance exercise One group receives individual endurance training and the other group a combination of individual endurance and strength training Both treatment groups will be treated twice a week for 12 weeks The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group as well as between the two exercise therapy approaches
The primary aim is to investigate the impact of exercise on V02peak Secondarily endpoints aim to investigate changes in physical function patient related outcomes and cardiac function before and after exercise
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None