Impact of Radiation Therapy on Lung Function in Breast Cancer Patients
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
This study is testing how radiation therapy affects lung function in breast cancer patients to help create better ways to prevent and treat lung problems after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Meshalkin Research Institute of Pathology of Circulation Research network |
| Drugs / interventions | radiation |
| Locations | 1 site (Novosibirsk, Novosibirsk Oblast) |
| Trial ID | NCT06069115 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess the effects of radiation therapy on lung function and oxygen metabolism in patients diagnosed with breast cancer. It involves monitoring pulmonary ventilation, gas exchange, and cardiovascular reserve capabilities during the treatment process. The study will utilize various tests, including pulmonary function tests and cardiopulmonary exercise testing, to establish risk stratification algorithms for post-radiation lung disorders. The ultimate goal is to develop a prevention and rehabilitation program for lung damage associated with breast cancer treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a confirmed diagnosis of malignant breast neoplasm who are about to undergo radiation therapy.
Not a fit: Patients with contraindications to inhaled corticosteroids or those with significant lung diseases requiring baseline therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and rehabilitation strategies for lung injuries in breast cancer patients undergoing radiation therapy.
How similar studies have performed: While similar studies have explored the effects of radiation on lung function, this specific approach focusing on breast cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Novosibirsk, Novosibirsk Oblast
- Meshalkin Scientific Research Center of the Ministry of Health of Russia — Novosibirsk, Novosibirsk Oblast, Russia (Recruiting)
Study contacts
- Principal investigator: Oksana Kamenskaya, PhD, MD — Meshalkin Scientific Research Center of the Ministry of Health of Russia
- Study coordinator: Oksana Kamenskaya, PhD, MD
- Email: o_kamenskaya@meshalkin.ru
- Phone: +79139458972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.