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Radiotherapy Exposed Lung Injury: Effect on Functioning - Cohort

Recruitingn/aAges 18 Years - anyFemaleMeshalkin Research Institute of Pathology of Circ…
NCT06069115 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * established diagnosis of malignant breast neoplasm; * signed informed voluntary consent of the patient to participate in the study. Exclusion Criteria: * contraindications to the use of inhaled corticosteroids (presence of active or inactive pulmonary tuberculosis, fungal, viral or bacterial infection of the respiratory organs); * lung diseases requiring baseline therapy with glucocorticosteroids (chronic obstructive pulmonary disease, bronchial asthma); * mental and/or musculoskeletal impairments that make it impossible to adequately perform the exercise test, cooperate with the patient and interpret the results; * conditions and diseases requiring emergency surgical intervention and/or observation and treatment in an ICU setting; * patient's refusal to participate in this clinical trial at any stage of the study.
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What it tests

  • Radiation therapy protocol for Breast cancer
  • Spirography and assessment of pulmonary diffusion capacity
  • Cardiopulmonary stress test
  • Computed tomography of the chest organs
  • SF-36 Quality of Life Questionnaire
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Where

1 site
Meshalkin Scientific Research Center of the Ministry of Health of Russia
Novosibirsk, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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