Actively Recruiting
Investigation of Oxygen Metabolism and Reserve Capabilities of Cardiovascular and Respiratory Systems in Patients with Malignant Neoplasms of the Breast in the Course of Complex Treatment
Led by Meshalkin Research Institute of Pathology of Circulation · Updated on 2025-02-11
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how oxygen metabolism and the reserve abilities of the heart and lungs change during the complex treatment of breast cancer. This prospective cohort study aims to understand lung function, gas exchange, and heart-lung exercise capacity in patients receiving radiation therapy for breast neoplasms. The goal is to develop prevention and rehabilitation programs for lung damage caused by cancer treatment and to analyze how these changes impact quality of life and emotional health. All participants will undergo a 5-week course of radiation therapy following breast cancer surgery. Different radiation schemes are used based on disease stage and surgery type, targeting the breast, chest wall, and lymph nodes with specific doses. Before and after radiation, patients will have lung function tests including spirography, pulmonary diffusion assessment, cardiopulmonary exercise testing, and chest CT scans to evaluate lung and heart-lung function. Questionnaires assessing quality of life, general health status, respiratory symptoms, anxiety, depression, and cognitive function will also be completed. Participants will be closely monitored with repeated tests after radiation therapy to measure peak oxygen consumption, lung diffusion capacity, and quality of life over 3 to 6 months and longer-term outcomes such as 1-year mortality. Data collected includes disease stage, surgery type, medications, complications, nutritional and psychological status. Statistical analyses will investigate relationships between lung and heart function changes and patient outcomes to guide future prevention and rehabilitation efforts. Total participation includes baseline and follow-up assessments over several months.
CONDITIONS
Brief 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 such as active or inactive pulmonary tuberculosis, fungal, viral or bacterial respiratory infections
- Lung diseases requiring baseline glucocorticosteroid therapy like chronic obstructive pulmonary disease or bronchial asthma
- Mental or musculoskeletal impairments that prevent adequate exercise testing or cooperation
- Conditions requiring emergency surgery or intensive care observation and treatment
- Patient refusal to participate at any stage of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 days
Participants undergo multiple diagnostic tests including pulmonary function tests, cardiopulmonary stress testing, indirect calorimetry, chest CT scan, and complete quality of life and symptom questionnaires to assess their baseline respiratory and cardiovascular function and general health status.
1 to 2 visits (in-person)
Duration - Approximately 4 to 6 weeks
Participants are observed during their course of radiation therapy for breast cancer, which occurs 4-12 weeks after surgery using different radiation schemes depending on disease characteristics.
Visits aligned with radiation therapy schedule
Duration - 1 week after radiation therapy
Repeated cardiopulmonary stress testing and pulmonary function tests are performed in the first week after completion of radiation therapy to evaluate changes in respiratory and cardiovascular function.
1 visit (in-person)
Duration - 3 years
Participants are followed for up to 3 years to monitor lung diffusion capacity, quality of life, and mortality outcomes.
Periodic follow-up visits up to 3 years
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
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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