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A study to evaluate the occurrence of pneumonitis in breast cancer patients who have received radiotherapy .

A prospective study to evaluate the occurrence of pneumonitis following adjuvant radiotherapy in breast cancer patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/09/036438
Enrollment
176
Registered
2021-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J701- Chronic and other pulmonary manifestations due to radiation

Interventions

None listed

Sponsors

Svims tirupati
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Histopathologically proven carcinoma breast patients 2 patients who underwent mastectomy or breast conservation surgery and received neo adjuvant or adjuvant systemic chemotherapy. 3 ECOG performance status of 0-2 4 patients willing to give an aproved informed consent.

Exclusion criteria

Exclusion criteria: 1 patients with history of radiation to breast,chest wall,thorax. 2 patients with known distant metastasis. 3 patients with ECOG performance status of 3-4 4 pregnant women lactating mother 5 patients with infective cause of pneumonitis.

Design outcomes

Primary

MeasureTime frame
To evaluate the incidence and severity of pneumonitis among breast cancer patients receiving adjuvant radiotherapyTo study the following parameters for evaluation Grades of early and late pneumonitis ( RTOG/EORTC Early radiation morbidity scoring scheme). 2 Association between clinical symptoms and radiological changes of pneumonitis 3 Association between mean lung dose and the risk of radiation pneumonitis Timepoint: Outcome will be assessed at baseline, during the course of radiotherapy , at 3 months and 9 months.

Secondary

MeasureTime frame
clinical and radiological association of radiation pneumonitis.Timepoint: patients are reviewed on weekly basis on the days of radiotherapy.And for every 3 months and 6 months thoracic CT will be done to grade the pneumonitis radiologically.

Countries

India

Contacts

Public ContactS SOUBHAGYAVATI SUSAN

svims tirupati

daspranabandhu@gmail.com9493547731

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026