Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Radiation Induced Fibrosis | — | UNRESOLVED | — |
| Radiation Pneumonia | — | UNRESOLVED | — |
| Radiation Pneumonitis | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiopulmonary stress test | Diagnostic Test | — | UNRESOLVED |
| Computed tomography of the chest organs | Diagnostic Test | — | UNRESOLVED |
| Demographic and anthropometric measures | Diagnostic Test | — | UNRESOLVED |
| Indicators characterizing the severity of the underlying disease | Other | — | UNRESOLVED |
| Radiation therapy protocol for Breast cancer | Radiation | — | UNRESOLVED |
| SF-36 Quality of Life Questionnaire | Diagnostic Test | — | UNRESOLVED |
| Spirography and assessment of pulmonary diffusion capacity | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Main cohort group
- description
- All participants will be included in the same group, with no subgrouping within this study.
- interventionNames
- Radiation: Radiation therapy protocol for Breast cancer
- Diagnostic Test: Spirography and assessment of pulmonary diffusion capacity
- Diagnostic Test: Cardiopulmonary stress test
- Diagnostic Test: Computed tomography of the chest organs
- Diagnostic Test: SF-36 Quality of Life Questionnaire
- Diagnostic Test: Demographic and anthropometric measures
- Other: Indicators characterizing the severity of the underlying disease
Primary outcomes (1)
- measure
- Peak oxygen consumption (VO2peak)
- timeFrame
- 3-6 months
- description
- Patient's data of spirometry will be compared between values before the radiotherapy and 3 to 6 months after.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available