Actively Recruiting
Radiotherapy Exposed Lung Injury: Effect on Functioning - Cohort
Led by Meshalkin Research Institute of Pathology of Circulation · Updated on 2025-02-11
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective cohort research to study the state of oxygen metabolism, reserve capabilities of cardiovascular and respiratory systems in patients with breast cancer to create a program of prevention and rehabilitation of lung damage in the process of complex treatment of the disease. The aim of the study is to study the dynamics of oxygen metabolism and reserve capabilities of cardiovascular and respiratory systems in the process of complex treatment of breast neoplasias. Objectives of the study: 1. Explore the dynamics of pulmonary ventilation and gas exchange disorders in patients with breast cancer in the course of radiation therapy 2. Establish an algorithm for risk stratification of post-radiation disorders of pulmonary ventilation and gas exchange in patients with breast cancer. 3. Analyze the prognostic significance of cardiopulmonary exercise testing in assessing the cardiotoxic effect of chemo- and radiation therapy in patients with breast cancer. 4. Analyze the influence of post-radiation disorders of pulmonary ventilation and gas exchange on the quality of life and psycho-emotional status of patients with breast cancer. 5. Develop a fundamental basis for the program of prevention and rehabilitation of post-radiation lung damage in patients with breast neoplasias based on the study of individual parameters of oxygen metabolism and reserve capabilities of cardiovascular and respiratory systems. All participants go through 5-week radiation therapy in standard protocol, will have investigation of their lung functioning by spirography and assessment of pulmonary diffusion capacity, cardiopulmonary stress tests and CT-scan on the lungs before radiotherapy course. Researchers will analyze such parameters as stage of the disease, surgery type, all patient's medications, complications, nutritional status, psychological status.
CONDITIONS
Official Title
Radiotherapy Exposed Lung Injury: Effect on Functioning - Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of malignant breast neoplasm
- Signed informed voluntary consent to participate in the study
You will not qualify if you...
- Contraindications to inhaled corticosteroids, including active or inactive pulmonary tuberculosis, fungal, viral, or bacterial respiratory infections
- Lung diseases requiring baseline glucocorticosteroid therapy such as chronic obstructive pulmonary disease or bronchial asthma
- Mental or musculoskeletal impairments preventing safe exercise testing, cooperation, or result interpretation
- Conditions needing emergency surgery or intensive care observation and treatment
- Refusal to participate in the clinical trial at any stage
AI-Screening
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Trial Site Locations
Total: 1 location
1
Meshalkin Scientific Research Center of the Ministry of Health of Russia
Novosibirsk, Novosibirsk Oblast, Russia, 630055
Actively Recruiting
Research Team
O
Oksana Kamenskaya, PhD, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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