Radiotherapy Exposed Lung Injury: Effect on Functioning - Cohort

NCT06069115 | Recruiting

• 1 other identifier: 584-н
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.Explore the dynamics of pulmonary ventilation and gas exchange disorders in patients with breast cancer in the course of radiation therapy
2. 2.Establish an algorithm for risk stratification of post-radiation disorders of pulmonary ventilation and gas exchange in patients with breast cancer.
3. 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. 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. 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.

Conditions

Breast Neoplasms; Radiation Pneumonia; Radiation Pneumonitis; Radiation Induced Fibrosis

Keywords

breast cancer; radiation therapy; radiation induced lung fibrosis

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption (VO2peak)

  Patient's data of spirometry will be compared between values before the radiotherapy and 3 to 6 months after.

  3-6 months

Secondary Outcomes (3)

• Quality of life as measured by the SF-36 questionnaire.

  3-6 months

• 1-year mortality from any cause

  1, 2, 3 years

• Dynamics of lung diffusion capacity (∆DLCO)

  3-6 months

Study Arms (1)

Main cohort group

All participants will be included in the same group, with no subgrouping within this study.

Radiation: Radiation therapy protocol for Breast cancer; Diagnostic Test: Spirography and assessment of pulmonary diffusion capacity; Diagnostic Test: Cardiopulmonary stress test; Diagnostic Test: Computed tomography of the chest organs; Diagnostic Test: SF-36 Quality of Life Questionnaire; Diagnostic Test: Demographic and anthropometric measures; Other: Indicators characterizing the severity of the underlying disease

Interventions

Radiation therapy protocol for Breast cancer RADIATION

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).

Main cohort group

Spirography and assessment of pulmonary diffusion capacity DIAGNOSTIC_TEST

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

Main cohort group

Cardiopulmonary stress test DIAGNOSTIC_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.

Main cohort group

Computed tomography of the chest organs DIAGNOSTIC_TEST

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.

Also known as: MSCT

Main cohort group

SF-36 Quality of Life Questionnaire DIAGNOSTIC_TEST

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

Main cohort group

Demographic and anthropometric measures DIAGNOSTIC_TEST

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

Main cohort group

Indicators characterizing the severity of the underlying disease OTHER

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.

Main cohort group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Inborn females with all inclusion criteria are eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• established diagnosis of malignant breast neoplasm;
• signed informed voluntary consent of the patient to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Meshalkin Scientific Research Center of the Ministry of Health of Russia

Novosibirsk, Novosibirsk Oblast, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Radiation Pneumonitis; Radiation Fibrosis Syndrome

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Radiation Injuries; Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Oksana Kamenskaya, PhD, MD

  Meshalkin Scientific Research Center of the Ministry of Health of Russia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oksana Kamenskaya, PhD, MD

CONTACT

+79139458972; o_kamenskaya@meshalkin.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 5, 2023
• Study Start: July 18, 2023
• Primary Completion (Estimated): July 18, 2026
• Study Completion (Estimated): July 18, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)