EARLY

Name and Title

Evaluation of Asymptomatic Radiation Induced Lung Injury (EARLY) Study

Recruitment status

Open

Chief investigator

Dr Raj Shrimali

Sponsor

University Hospitals Coventry & Warwickshire NHS Trust       

Aim

To record and analyse the actual impact of radical radiotherapy treatment (with or without chemotherapy) on the typical trend and average decline in Lung function, compared to baseline

Study design

Single centre, prospective cohort pilot study

Speciality

Oncology and Respiratory Physiology

Sample size

70

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.

In this study, regardless of whether they have symptoms or not, we aim to repeat the tests assessing respiratory physiology at defined time points (3, 6, 12 months) after radiotherapy treatment. Furthermore, we aim to explore whether these tests 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.

Planned start date

06/12/2019

Planned duration

3.5 years

Enquiries

Tel: 02476 967151

Email: kay.sanders@uhcw.nhs.uk