NCT06069115 Radiotherapy Exposed Lung Injury: Effect on Functioning - Cohort
| NCT ID | NCT06069115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meshalkin Research Institute of Pathology of Circulation |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-07-18 |
| Primary Completion | 2026-07-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-07-18 with a primary completion date of 2026-07-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Oksana Kamenskaya, PhD, MD
PRINCIPAL INVESTIGATOR
Meshalkin Scientific Research Center of the Ministry of Health of Russia
Frequently Asked Questions
Who can join the NCT06069115 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06069115 currently recruiting?
Yes, NCT06069115 is actively recruiting participants. Contact the research team at o_kamenskaya@meshalkin.ru for enrollment information.
Where is the NCT06069115 trial being conducted?
This trial is being conducted at Novosibirsk, Russia.
Who is sponsoring the NCT06069115 clinical trial?
NCT06069115 is sponsored by Meshalkin Research Institute of Pathology of Circulation. The principal investigator is Oksana Kamenskaya, PhD, MD at Meshalkin Scientific Research Center of the Ministry of Health of Russia. The trial plans to enroll 200 participants.