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
Meshalkin Research Institute of Pathology of Circulation
200 participants
Jul 18, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria2
- established diagnosis of malignant breast neoplasm;
- signed informed voluntary consent of the patient to participate in the study.
Exclusion Criteria5
- 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.
Interventions
Conformal 3D radiation therapy will be performed 4-12 weeks after surgical treatment of breast cancer on Electa Axesse linear gas pedal with 6 MeV energy in traditional fractionation mode. Different RT schemes will be used depending on the stage of the disease, type of surgical treatment, and morphological variant of the tumor. In organ-preserving surgeries the remaining breast will be irradiated with a single focal dose (FD) of 2 Gy, up to the total focal dose (TFD) of 50 Gy. In the presence of risk factors, irradiation of lymphatic outflow pathways will be performed: axillary, sub/adclavicular and parasternal lymph nodes areas (FD 2 Gy, up to TFD 44-46 Gy). In radical breast resection we'll use irradiation of the anterior chest wall in 2 Gy FD, up to 50 Gy FD, irradiation of lymphatic outflow pathways: axillary, sub/adclavicular and parasternal lymph nodes (2 Gy FD, up to 44-46 Gy FD).
Using the Master Screen Body device you will be asked to take two series of breaths through a special tube for 2-3 minutes. Usually the procedure does not cause any discomfort
The exercise test is performed on a bicycle ergometer Oxycon Pro. Prior to the test, special sensors for recording the electrocardiogram, a sensor to determine blood saturation, and a cuff to measure blood pressure will be glued on the body. Breathing during the test takes place through a face mask with a built-in gas analyzer sensor. The stress test is conducted up to an individual maximum (according to the age, sex, height and weight of the patient), followed by a recovery period. There is some temporary discomfort associated with performing physical activity. Dyspnea, leg fatigue, and dizziness may occur. Observation continues until full recovery of hemodynamic and gas exchange parameters, in case of appearance of unfavorable symptoms - until their disappearance.
CT is a method of examination based on X-rays, but unlike conventional X-rays, it gives the most complete picture of the body structure, with less radiation. Tomography usually does not cause any unpleasant feelings and is performed in a specialized department.
Standard questionnaire for assessment quality of patient's life https://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf
Age, sex, height. weight, body mass index (BMI)
Severity of underlying disease (mMRC, BODE, SMRT-CO Respiratory Support Need Scale), and comorbidities (cardiovascular disease, diabetes mellitus, chronic obstructive pulmonary disease, chronic kidney disease) Medications taken.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06069115