Radiotherapy Exposed Lung Injury: Effect on Functioning - Cohort

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

July 18, 2023

Primary Completion Date

July 18, 2026

Study Completion Date

July 18, 2026

Conditions
Breast NeoplasmsRadiation PneumoniaRadiation PneumonitisRadiation Induced Fibrosis
Interventions
RADIATION

Radiation therapy protocol for Breast cancer

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).

DIAGNOSTIC_TEST

Spirography and assessment of pulmonary diffusion capacity

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

DIAGNOSTIC_TEST

Cardiopulmonary stress test

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.

DIAGNOSTIC_TEST

Computed tomography of the chest organs

"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."

DIAGNOSTIC_TEST

SF-36 Quality of Life Questionnaire

Standard questionnaire for assessment quality of patient's life https://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf

DIAGNOSTIC_TEST

Demographic and anthropometric measures

Age, sex, height. weight, body mass index (BMI)

OTHER

Indicators characterizing the severity of the underlying disease

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.

Trial Locations (1)

630055

RECRUITING

Meshalkin Scientific Research Center of the Ministry of Health of Russia, Novosibirsk

All Listed Sponsors
lead

Meshalkin Research Institute of Pathology of Circulation

NETWORK