Protocol for Exercise Program in Cancer and Cognition (EPICC): A randomized controlled trial of the effects of aerobic exercise on cognitive function in postmenopausal women with breast cancer receiving aromatase inhibitor therapy

Contemp Clin Trials. 2018 Apr;67:109-115. doi: 10.1016/j.cct.2018.02.012. Epub 2018 Mar 6.

Abstract

The Exercise Program in Cancer and Cognition (EPICC) Study is a randomized controlled trial designed to test the effects of moderate-intensity aerobic exercise on cognitive function in postmenopausal women with early-stage breast cancer during the first six months of aromatase inhibitor therapy. It is estimated that up to 75% of survivors of breast cancer experience cognitive impairment related to disease and treatment. At present, there are no known interventions to improve or manage cognitive function for women with breast cancer. Here, we describe a single-blinded, randomized controlled trial with allocation of 254 postmenopausal women with early-stage breast cancer to a supervised six-month aerobic exercise intervention or usual care. Prior to beginning aromatase inhibitor (AI) therapy, participants complete baseline assessments of cognitive function, cardiorespiratory fitness, blood-based biomarkers, physical activity and sleep, and symptoms (fatigue, sleep problems, depressive symptoms, anxiety). A random subset of participants (n = 150) undergoes neuroimaging procedures that include structural and functional magnetic resonance imaging assessments. All participants maintain an activity diary; physical activity and sleep monitoring is repeated three and seven months post-randomization. The remaining baseline assessments are repeated seven months post-randomization. If successful, exercise could be a low-cost method to improve cognitive function in women with breast cancer that is easily adaptable to the home or community.

Trial registration: Clinicaltrials.govNCT02793921. Registered 20 May 2016.

Keywords: Aerobic exercise; Aromatase inhibitor; Breast cancer; Cognitive function; Neuroimaging; Randomized controlled trial.

Publication types

  • Clinical Trial Protocol
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Antineoplastic Agents / therapeutic use
  • Aromatase Inhibitors / therapeutic use*
  • Breast Neoplasms* / drug therapy
  • Breast Neoplasms* / psychology
  • Breast Neoplasms* / therapy
  • Cognition / physiology*
  • Depression* / etiology
  • Depression* / therapy
  • Exercise / psychology*
  • Exercise Therapy* / methods
  • Exercise Therapy* / psychology
  • Female
  • Functional Neuroimaging / methods
  • Humans
  • Quality of Life*
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • Aromatase Inhibitors

Associated data

  • ClinicalTrials.gov/NCT02793921