A combined exercise and nutrition intervention to treat cancer-related fatigue, unhealthy weight gain, and impaired physical function

About This Grant

PROJECT SUMMARY Overview: Cancer-related fatigue (CRF) affects up to 91% of patients with breast cancer and can persist years beyond primary treatment in over half of survivors. Over 60% also experience unhealthy weight gain (UWG) causing them to become obese. CRF and obesity are debilitating toxicities that synergistically impair physical function, and negatively affect breast cancer survivors' recovery, quality of life, morbidity, and mortality. CRF and UWG are hypothesized to frequently co-occur due to a shared underlying pathophysiology of dysregulated circadian function. Primary cancer treatments and adjuvant endocrine therapies prescribed to 80% of breast cancer survivors disrupt circadian rhythms. We propose to intervene on CRF and UWG by utilizing two of the strongest behavioral regulators of circadian function (i.e., exercise and healthy eating timeframes). Preliminary work by our group suggests that independently, two established interventions 1) a home-based progressive walking and resistance exercise regimen (EXCAP©®) and 2) a 10-hour healthy eating timeframe (hEAT), may mitigate CRF and UWG. Despite promising rationale that the combined intervention would improve effect sizes and adherence, the combined intervention has never been tested among breast cancer survivors. Research Plan: In the K99, we will first develop and adapt the novel combined intervention (EXCAP-hEAT) by obtaining feedback from interviews with 10 breast cancer survivors. Second, we will conduct a phase I single- arm trial to optimize the acceptability, adherence, and barriers to adherence of the novel EXCAP-hEAT intervention among 20 fatigued and overweight or obese breast cancer survivors receiving adjuvant endocrine therapy. In the R00, we will conduct a phase II randomized controlled trial to assess the preliminary efficacy of the newly adapted and refined EXCAP-hEAT intervention versus usual care on CRF (primary outcome), weight, and impaired physical function among 60 fatigued and overweight or obese breast cancer survivors receiving adjuvant endocrine therapy. We will also explore the effect of EXCAP-hEAT on dysregulated circadian function. Career Development Plan: Dr. Mattick is an early-career investigator in the fields of cancer control and translational science focused on developing and testing behavioral interventions to mitigate cancer-related toxicities as well as conducting multi-disciplinary translational studies. The K99/R00 allows Dr. Mattick to acquire skills to become an independent investigator who can design and conduct behavioral clinical trials. Dr. Mattick's mentoring team has extensive expertise in exercise oncology, nutrition interventions, translational science, medical oncology, bioinformatics, and biostatistics. Impact: The proposed research and training plan will ensure Dr. Mattick's transition to independence by providing the skills and preliminary data required to successfully compete for future R01-level grants. The proposed research is the first to evaluate the acceptability and preliminary efficacy of EXCAP-hEAT, which may mitigate CRF, UWG, and impaired physical function by regulating circadian function among breast cancer survivors.