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

Status: Recruiting
Location: See location...
Intervention Type: Other, Radiation, Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• established diagnosis of malignant breast neoplasm;

• signed informed voluntary consent of the patient to participate in the study.

Locations
Other Locations
Russian Federation
Meshalkin Scientific Research Center of the Ministry of Health of Russia
RECRUITING
Novosibirsk
Contact Information
Primary
Oksana Kamenskaya, PhD, MD
o_kamenskaya@meshalkin.ru
+79139458972
Time Frame
Start Date: 2023-07-18
Estimated Completion Date: 2026-07-18
Participants
Target number of participants: 200
Treatments
Main cohort group
All participants will be included in the same group, with no subgrouping within this study.
Sponsors
Leads: Meshalkin Research Institute of Pathology of Circulation

This content was sourced from clinicaltrials.gov