EARLY
Research type
Research Study
Full title
Evaluation of Asymptomatic Radiation Induced Lung Injury
IRAS ID
259254
Contact name
Raj Shrimali
Contact email
Sponsor organisation
University Hospitals Coventry and Warwickshire NHS Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Radiotherapy is commonly used for treatment of lung or oesophageal cancers, and radiation-induced lung damage (pneumonitis and fibrosis) is recognised as a complication. Pulmonary function tests (PFT), also known as lung function tests, are breathing tests designed to show how well the lungs and airways are working and delivering oxygen to the bloodstream. PFT are routinely carried out before radiotherapy to assess whether a patient’s lungs are fit to receive this treatment. However, these tests are not usually repeated after radiotherapy unless a patient has overt symptoms.
We aim to study how the PFT, the capillary blood gas measurements and the patient-reported symptoms change over time, after radiotherapy. Furthermore, we aim to understand whether these changes in PFT have any effect on the symptoms that patients experience. Patients who will receive high doses of radiotherapy for lung or oesophageal cancer would be invited to participate in this study. In this study, regardless of whether they have symptoms or not, we aim to repeat PFT, capillary blood gas measurements at defined time points (3, 6, 12 months) after radiotherapy treatment. Furthermore, we aim to explore whether PFT and blood gas parameters show any correlation with respiratory symptoms as reported in St George’s Respiratory Questionnaire (SGRQ).
These extra tests do not involve any exposure to radiation and are minimally invasive. This study is not testing any intervention or treatment, and does not require the patients to take any extra medications. We would try and schedule these tests to take place on the same day as routine follow-up clinic appointment, as far as possible.
In this study (pilot phase) we are aiming to recruit 70 patients, over 2.5 years, and the study will close when the last patient has completed the final assessment at 1 year, after radiotherapy.REC name
North West - Preston Research Ethics Committee
REC reference
19/NW/0260
Date of REC Opinion
21 Jun 2019
REC opinion
Further Information Favourable Opinion