Prospective Randomized Trial Comparing 2 Devices for Deep Inspiration Breath Hold Management in Breast Radiation Therapy: Results of the BRAVEHeart Trial

Abstract

Aims: The BRAVEHeart trial prospectively randomized left-sided breast cancer patients to one of two deep inspiration breath hold (DIBH) biofeedback devices: a novel chest surface tracking system and an abdominal block tracking system. The primary hypothesis was that the accuracy of chest tracking would be higher than that of abdominal tracking as the chest is a more direct surrogate of the breast target.Methods: Left-sided breast cancer patients were treated in DIBH with IMRT delivery. Patients were randomized to either the novel chest surface system or abdominal block system for active management of breath hold with visual feedback. On both trial arms the unallocated system monitored passively.239,296 cine EPID images were analyzed retrospectively to extract the chest wall position. Treatment accuracy was quantified as the deviation of the internal chest wall during treatment relative to the planned position from the digitally reconstructed radiograph. The correlation between motion of the external surrogate and internal chest wall was calculated per breath hold. Ease of use was assessed with questionnaires for both radiation therapists and patients and appointment length recorded.Results: Data from 26 participants were available for analysis. No difference was found in delivered treatment accuracy between arms. Across all patients and fractions, the median correlation between internal chest wall movement and external surrogate was 0.69 for the chest surface and 0.17 for the abdominal block. Patients found it easy to follow visual feedback from both systems. No difference was found in appointment length between arms.Conclusions: No statistical evidence was found for superior treatment accuracy, satisfaction or appointment length for the novel chest surface tracking device compared to the abdominal block system. During DIBH, the median per-breath hold correlation of internal chest wall movement to the motion of the chest surface was higher than the median correlation of the abdominal block to the chest surface.