Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06069115
Status:
RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-10-01
Brief Title:
Radiotherapy Exposed Lung Injury Effect on Functioning - Cohort
Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Organization:
Meshalkin Research Institute of Pathology of Circulation
Study Overview
Official Title:
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
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RELIEF-COHORT
Brief 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 patients medications complications nutritional status psychological status
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 patients medications complications nutritional status psychological status
Detailed Description:
After a discussion about the possibility of participating in the study the patient is presented with an informed consent form and all questions of interest are explained If consent to participate in the study is obtained the patient and the researcher fill in all the required fields of two copies of the informed consent form and sign it If necessary the researcher re-explains any information regarding the study One copy of the informed consent remains with the patient and the second copy is kept as required by Good Clinical Practice by the researcher
Once informed consent has been obtained an Individual Registration Card IRC is completed for the patient included in the study Completion of the IRC also continues until all phases of the study are completed
Pulmonary function tests cardiopulmonary stress testing CPST indirect calorimetry are performed in patients with breast cancer who have undergone surgical treatment of the disease and referred for radiation therapy in the FGBU NMC named after EN Meshalkin of the Ministry of Health of Russia using MasterScreen Pneumo Jaeger Germany Oxycon Pro ergospirometry Jaeger Germany and indirect calorimetry systems for evaluation of external respiratory function in accordance with international standards External respiration indices were adjusted to BTPS conditions body temperature 37C ambient pressure and gas saturated with water vapor and gas exchange - STPD standard temperature 0C or 273 K and pressure 760 mm Hg and no water vapor The protocol of stress testing is selected individually based on the proper values in accordance with the age sex and anthropometric data of the patient The study is conducted up to the individual maximum followed by a recovery period The anaerobic threshold is determined using the V-slope method After reaching the peak load it is gradually reduced Observation continues until full recovery of hemodynamic parameters gas exchange in case of adverse symptoms - until their disappearance Repeated testing is performed in the first week after the end of the course of radiation therapy
MSCT of the chest is performed on the 1-2 day of patient inclusion in the study to assess the initial state of the bronchopulmonary system of patients
The SF-36 quality of life questionnaire ECOG scale for assessing the general condition of the oncologic patient mMRC respiratory disturbance scale anxiety and depression scales postcovicular functional limitations scale and cognitive impairment scale are completed at inclusion in the study and after the course of radiation therapy
Statistical analysis
If the data are normally distributed they will be compared using t-test multivariate analysis of variance and χ2 test If the data are not normally distributed non-parametric tests will be used A 95 confidence interval will be applied when calculating the mean and standard deviationmedian and percentiles Dependencies between continuous quantitative variables will be studied using linear regression in case of discrete variables Spearman correlation will be used Binary logistic regression will be applied to study qualitative traits having 2 categories Manual stepwise variable inclusion technique will be used to formulate multivariate regression models with a cut-off point of significance level of 020 In all other cases statistical significance will be established at a probability of type one error of less than 5 All statistical analyses will be blinded
Once informed consent has been obtained an Individual Registration Card IRC is completed for the patient included in the study Completion of the IRC also continues until all phases of the study are completed
Pulmonary function tests cardiopulmonary stress testing CPST indirect calorimetry are performed in patients with breast cancer who have undergone surgical treatment of the disease and referred for radiation therapy in the FGBU NMC named after EN Meshalkin of the Ministry of Health of Russia using MasterScreen Pneumo Jaeger Germany Oxycon Pro ergospirometry Jaeger Germany and indirect calorimetry systems for evaluation of external respiratory function in accordance with international standards External respiration indices were adjusted to BTPS conditions body temperature 37C ambient pressure and gas saturated with water vapor and gas exchange - STPD standard temperature 0C or 273 K and pressure 760 mm Hg and no water vapor The protocol of stress testing is selected individually based on the proper values in accordance with the age sex and anthropometric data of the patient The study is conducted up to the individual maximum followed by a recovery period The anaerobic threshold is determined using the V-slope method After reaching the peak load it is gradually reduced Observation continues until full recovery of hemodynamic parameters gas exchange in case of adverse symptoms - until their disappearance Repeated testing is performed in the first week after the end of the course of radiation therapy
MSCT of the chest is performed on the 1-2 day of patient inclusion in the study to assess the initial state of the bronchopulmonary system of patients
The SF-36 quality of life questionnaire ECOG scale for assessing the general condition of the oncologic patient mMRC respiratory disturbance scale anxiety and depression scales postcovicular functional limitations scale and cognitive impairment scale are completed at inclusion in the study and after the course of radiation therapy
Statistical analysis
If the data are normally distributed they will be compared using t-test multivariate analysis of variance and χ2 test If the data are not normally distributed non-parametric tests will be used A 95 confidence interval will be applied when calculating the mean and standard deviationmedian and percentiles Dependencies between continuous quantitative variables will be studied using linear regression in case of discrete variables Spearman correlation will be used Binary logistic regression will be applied to study qualitative traits having 2 categories Manual stepwise variable inclusion technique will be used to formulate multivariate regression models with a cut-off point of significance level of 020 In all other cases statistical significance will be established at a probability of type one error of less than 5 All statistical analyses will be blinded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None