NCT06069115Recruiting
Radiotherapy Exposed Lung Injury: Effect on Functioning - Cohort
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
Source: ClinicalTrials.gov · Last updated 11 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 1 Oct 2023
- Start date
- 18 Jul 2023
- Primary completion date
- 18 Jul 2026
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- NCT number
- NCT06069115
What you commit to
- Study type: Observational
- Planned participants: 200
- From 18 Jul 2023 to the primary completion date, 18 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
- conditions and diseases requiring emergency surgical intervention and/or observation and treatment in an ICU setting;
Other
- mental and/or musculoskeletal impairments that make it impossible to adequately perform the exercise test, cooperate with the patient and interpret the results;
- patient's refusal to participate in this clinical trial at any stage of the study.
Who the study is looking for
- established diagnosis of malignant breast neoplasm;
- signed informed voluntary consent of the patient to participate in the study.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Meshalkin Scientific Research Center of the Ministry of Health of Russia Coordinator of this site? Confirm its status | Novosibirsk | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.