Discussion
metabolic and/or cardiovascular dysfunction, breast cancer, Metabolic toxicity, metabolic dysfunction, active cancer
SIDE EFFECT, BREAST CANCER, CVD, RECRUITMENT, EVENTS
Metabolic toxicity is an important emerging side effect from chemotherapy treatment resulting in rapid onset of metabolic dysfunction and persistent impairments after treatment completionOur intervention is designed to address potential barriers to adherence common among patients receiving active cancer treatment. For example, we incorporated guidelines that allow participants to deviate from strict TRE in ways that are still supported by evidence for cardiometabolic health effects, including altering the length of TRE, selecting the start time of their eating window and guidance for taking a day off from TRE when required. Accounting for personal preferences in health interventions has been found to enhance recruitment and foster participant autonomy, enjoyment, and intervention adherenceA strength of this study is the use of 3T MRI as a non-invasive, safe (no ionising radiation), and highly reproducible technique to quantify the primary outcome (visceral AT), and other ectopic AT pools in the liver and thigh muscles. Our study will provide novel additions to the emerging evidence that rapid expansion of ectopic AT pools and their associated metabolic and/or cardiovascular dysfunction during breast cancer treatment plays a central role in the increased risk of CVD events among breast cancer survivors.We have taken steps to minimise potential sources of bias. While blinding participants and their care team is not possible due to behavioural nature of the intervention and for patient safety, all outcome assessors will be blinded to the group assignment. In addition, participants in the comparison group will receive the same number and timing of calls to control for social impact and to assess contamination. One limitation is that we are using a parallel study design to implement a multimodal intervention which limits our ability to determine the individual effects of each component of the intervention.In summary, the IMPACT-women study will evaluate the short- and longer-term effects of a multimodal metabolic health intervention during chemotherapy treatment for early-stage breast cancer on markers of metabolic health at the end of chemotherapy. The phone-based intervention consists of 