Abstract
BackgroundUp to 80% of breast cancer patients suffer from Cancer Related Cognitive Impairments (CRCI). Exercise is suggested as a potential supportive care option to reduce cognitive decline in cancer patients. This study will investigate the effects of a high-intensity interval endurance training (HIIT) on CRCI in breast cancer patients. Potentially underlying immunological and neurobiological mechanisms, as well as effects on patients’ self-perceived cognitive functioning and common cancer related side-effects, will be explored.MethodsA single-blinded randomized controlled trial will be carried out. The impact of HIIT on CRCI will be compared to that of a placebo-intervention (supervised myofascial release training). Both interventions will be conducted simultaneously with the patients’ first-line chemotherapy treatment typically lasting 12–18 weeks. Fifty-nine women with breast cancer will be included in each of the two groups. The study is powered to detect (α = .05, β = .2) a medium effect size difference between the two groups (d = .5) in terms of patients’ change in cognitive testing performances, from baseline until the end of the exercise-intervention. The cognitive test battery, recommended by the International Cancer and Cognition Task Force to assess CRCI, will be used as primary measure. This includes the Hopkins Verbal Learning Test (learning/verbal memory), the Controlled Oral Word Association Test (verbal fluency) and the Trail-Making-Test A/B (attention/set-switching). The following endpoints will be assessed as secondary measures: Go-/No-Go test performance (response inhibition), self-perceived cognitive functioning, serum levels of pro- and antiinflammatory markers (tumor necrosis factor alpha, Interleukin-6, Interleukin-1 alpha, Interleukin-1 beta, C-reactive protein, Interleukin-1 receptor antagonist and Interleukin-10), serum levels of neurotrophic and growth factors (brain-derived neurotrophic factor, insulin-like growth factor 1 and vascular endothelial growth factor), as well as common cancer-related side effects (decrease in physical capacity, fatigue, anxiety and depression, sleep disturbances, quality of life and chemotherapy compliance).DiscussionThis study will provide data on the question whether HIIT is an effective supportive therapy that alleviates CRCI in breast cancer patients. Moreover, the present study will help shed light on the underlying mechanisms of potential CRCI improving effects of exercise in breast cancer patients.Trial registrationDRKS.de, German Clinical Trials Register (DRKS), ID: DRKS00011390, Registered on 17 January 2018.
Highlights
The following endpoints will be assessed as secondary measures: Go-/No-Go test performance, self-perceived cognitive functioning, serum levels of pro- and antiinflammatory markers, serum levels of neurotrophic and growth factors, as well as common cancer-related side effects
The following endpoints will be assessed as secondary measures: Go-/No-Go-test performance, self-perceived cognitive performance, serum levels of pro- and antiinflammatory markers (TNF-α, IL-6, Interleukin 1 Alpha (IL-1α), IL-1β, C-reactive protein (CRP), Interleukin-1 receptor antagonist (IL-1RA), IL-10), serum levels of neurotrophic and growth factors (BDNF, insulin-like growth factor 1 (IGF-1), vascular endothelial growth factor (VEGF)) as well as common cancer-related side effects
Based on attrition rate reported in existing studies applying high-intensity interval endurance training (HIIT) in breast cancer patients during chemotherapy [49, 51] we accounted for 15% drop-out rate, leading to a total sample size of N = 136 patients
Summary
Up to 80% of breast cancer patients suffer from Cancer Related Cognitive Impairments (CRCI). Exercise is suggested as a potential supportive care option to reduce cognitive decline in cancer patients. Up to 80% of breast cancer patients demonstrate a decrease in their cognitive capacity [1,2,3,4,5]. Cognitive decline in breast cancer patients is mostly attributed to chemotherapy [13,14,15] leading to the expression of “Chemobrain” [16]. Recent research shows that other factors, besides chemotherapy, can adversely impact cognition of breast cancer patients [17,18,19,20,21,22,23]. The term “Cancer Related Cognitive Impairment” (CRCI) is currently preferred in the scientific literature [24, 25]
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