InHALe: deep INspiration breath Hold setup Accuracy for LEft breast RT
Research type
Research Study
Full title
InHALe: A prospective cohort study evaluating the impact of deep INspiration breath Hold (DIBH) using the Varian Real-Time Position Management (RPM) system on inter-fraction set-up Accuracy during a course of LEft-sided breast radiotherapy in terms of tumour bed and heart position.
IRAS ID
164647
Contact name
David Wilson
Contact email
Sponsor organisation
University College London Sponsor Rep
Clinicaltrials.gov Identifier
15/0010, R&D Number
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Radiotherapy following breast conserving surgery significantly reduces the risk of the cancer coming back in the breast. However, for the majority of left-sided treatments some heart tissue will receive a high dose of radiation. Longterm side effects to the heart are well-documented with an increased risk of a major coronary event reported in patients following curative breast radiotherapy.
Traditionally, breast radiotherapy is delivered while a patient breathes normally. However, studies have shown that by taking a deep inspiration breath hold (DIBH), the heart can be moved out of the path of the radiotherapy beam, thereby minimising potential side effects to this organ. Installed at UCLH is a system called the Varian RPM, which is a medically approved device that guides the patient to achieve a DIBH during treatment.
Although a number of studies have described the advantages of delivering radiotherapy in DIBH, these studies report data at a single point in time; when a treatment plan is created in preparation for radiotherapy. Limited evidence exists looking at heart and breast radiation doses over a treatment course where daily variations in breath hold levels may occur. At UCLH, data from a pilot study (ref 14/0083) indicated differences in the amount of air breathed-in over a period of time when using this system. The main aim of this research is to evaluate whether differences in the amount of air breathed-in each day effect treatment accuracy, and doses to the heart and breast over a course of radiotherapy.
Lay Summary of results: The study closed early (only 6/25 patients recruited). Recruitment was paused in June 2019 due to the radiotherapy CT scanner being replaced over a number of months. A capacity issue followed whereby the department could not facilitate the additional resources for the trial in terms of CT scanner access. Recruitment was due to restart when the COVID-19 pandemic heavily impacted NHS capacity. COVID-19 infection control measures required additional cleaning requirements of the breathing equipment required in the study, which was not compatible with patient attendance. Between the initial study design in 2015, and 2022, when the trial was in a position to restart recruitment, breast radiotherapy technique and image verification had evolved, rendering the research question no longer relevant. CT scanning was now fully available on the treatment machines, and so the trial questions had been answered within standard clinical practice. No meaningful data could be concluded from the small number of patients recruited and there is therefore no associated publication.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
16/LO/0514
Date of REC Opinion
23 May 2016
REC opinion
Further Information Favourable Opinion