Journal Article

Protocol for the “Chemobrain in Motion – study” (CIM – study): a randomized placebo-controlled trial of the impact of a high-intensity interval endurance training on cancer related cognitive impairments in women with breast cancer receiving first-line chemotherapy

Bloch, Wilhelm, Joisten, Niklas, Schaffrath, Nils, Schmidt, Katharina, Zimmer, Philipp, Oberste, Max, Jäger, Elke, Steindorf, Karen, Hartig, Philipp

2018

Overview

Background 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. 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. Methods A 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). Discussion This 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 registration DRKS.de, German Clinical Trials Register (DRKS), ID: DRKS00011390 , Registered on 17 January 2018.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Aerobics / Aged / Anxiety / Anxiety - blood / Anxiety - complications / Anxiety - physiopathology / Anxiety - therapy / Biomedical and Life Sciences / Biomedicine / Brain research / Brain-derived neurotrophic factor / Breast cancer / Breast Neoplasms - blood / Breast Neoplasms - complications / Breast Neoplasms - pathology / Breast Neoplasms - therapy / C-reactive protein / Cancer / Cancer Research / Cancer therapies / Care and treatment / Chemobrain / Chemotherapy / Clinical trials / Cognition / Cognition & reasoning / Cognitive ability / Cognitive disorders / Cognitive Dysfunction - blood / Cognitive Dysfunction - complications / Cognitive Dysfunction - pathology / Cognitive Dysfunction - therapy / Cognitive impairment / Complications and side effects / Cytokines / Depression - blood / Depression - complications / Depression - physiopathology / Depression - therapy / Endurance Training / Exercise / Exercise Therapy / Fatigue / Female / Growth factors / Health aspects / Health Promotion and Disease Prevention / High intensity interval training / High-intensity interval endurance training / Humans / Insulin / Insulin-like growth factors / Interleukin 1 / Interleukin 1 receptor antagonist / Interleukin 10 / Interleukin 6 / Interleukins - blood / Learning / Medicine/Public Health / Memory / Mental depression / Methods / Neoplasm Staging / Oncology / Patients / Physical fitness / Physical Fitness - physiology / Quality of life / Risk factors / Serum levels / Side effects / Sleep / Studies / Study Protocol / Supportive therapy / Surgical Oncology / survivorship and psychosocial oncology / Tumor necrosis factor-TNF / Tumor necrosis factor-α / Vascular endothelial growth factor / Womens health