Trial Title:
Radiotherapy Exposed Lung Injury: Effect on Functioning - Cohort
NCT ID:
NCT06069115
Condition:
Breast Neoplasms
Radiation Pneumonia
Radiation Pneumonitis
Radiation Induced Fibrosis
Conditions: Official terms:
Pneumonia
Neoplasms
Breast Neoplasms
Radiation Pneumonitis
Fibrosis
Radiation Fibrosis Syndrome
Conditions: Keywords:
breast cancer
radiation therapy
radiation induced lung fibrosis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
Radiation therapy protocol for Breast cancer
Description:
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).
Arm group label:
Main cohort group
Intervention type:
Diagnostic Test
Intervention name:
Spirography and assessment of pulmonary diffusion capacity
Description:
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
Arm group label:
Main cohort group
Intervention type:
Diagnostic Test
Intervention name:
Cardiopulmonary stress test
Description:
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.
Arm group label:
Main cohort group
Intervention type:
Diagnostic Test
Intervention name:
Computed tomography of the chest organs
Description:
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.
Arm group label:
Main cohort group
Other name:
MSCT
Intervention type:
Diagnostic Test
Intervention name:
SF-36 Quality of Life Questionnaire
Description:
Standard questionnaire for assessment quality of patient's life
https://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf
Arm group label:
Main cohort group
Intervention type:
Diagnostic Test
Intervention name:
Demographic and anthropometric measures
Description:
Age, sex, height. weight, body mass index (BMI)
Arm group label:
Main cohort group
Intervention type:
Other
Intervention name:
Indicators characterizing the severity of the underlying disease
Description:
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.
Arm group label:
Main cohort group
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.
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 E.N. 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 (37°C), ambient
pressure and gas saturated with water vapor), and gas exchange - STPD (standard
temperature (0°C 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 deviation/median 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 0.20. 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.
Criteria for eligibility:
Study pop:
200 patients aged 18 years and older with established diagnosis of breast malignant
neoplasm, admitted to the Federal State Budgetary Institution "Meshalkin National Medical
Center" of the Ministry of Health of Russia to undergo a course of radiation therapy
Sampling method:
Probability Sample
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.
Gender:
Female
Gender based:
Yes
Gender description:
Inborn females with all inclusion criteria are eligible
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Meshalkin Scientific Research Center of the Ministry of Health of Russia
Address:
City:
Novosibirsk
Zip:
630055
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Oksana Kamenskaya, PhD, MD
Phone:
+79139458972
Email:
o_kamenskaya@meshalkin.ru
Start date:
July 18, 2023
Completion date:
July 18, 2026
Lead sponsor:
Agency:
Meshalkin Research Institute of Pathology of Circulation
Agency class:
Other
Source:
Meshalkin Research Institute of Pathology of Circulation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06069115
