Dataset Information

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.

ABSTRACT:

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 (??=?.05, ??=?.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.

SUBMITTER: Oberste M

PROVIDER: S-EPMC6220507 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Publications

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.

Oberste Max M Schaffrath Nils N Schmidt Katharina K Bloch Wilhelm W Jäger Elke E Steindorf Karen K Hartig Philipp P Joisten Niklas N Zimmer Philipp P

BMC cancer 20181106 1

<h4>Background</h4>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 c ...[more]

PMID: 30400840

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Project description:Cardiovascular and cardiometabolic diseases are leading causes of death worldwide. Exercise favorably affects this problem, however only few invest (enough) time to favorably influence cardiometabolic risk-factors and cardiac morphology/performance. Time-effective, high-intensity, low-volume exercise protocols might increase people's commitment to exercise. To date, most research has focused on high-intensity interval training (HIIT), the endurance type of HIT, while corresponding HIT-resistance training protocols (HIT-RT) are rarely evaluated. In this study we compared the effect of HIIT vs. HIT-RT, predominately on cardiometabolic and cardiac parameters in untrained, overweight-obese, middle-aged men. Eligible, untrained men aged 30-50 years old in full-time employment were extracted from two joint exercise studies that randomly assigned participants to a HIIT, HIT-RT or corresponding control group. HIIT predominately consisted of interval training 90 s-12 min, (2-4 sessions/week), HIT-RT (2-3 sessions/week) was applied as a single set resistance training to muscular failure. Core intervention length of both protocols was 16 weeks. Main inclusion criteria were overweight-obese status (BMI 25-35 kg/m2) and full employment (occupational working time: ≥38.5 h/week). Primary study-endpoint was the Metabolic Syndrome (MetS) Z-Score, secondary study-endpoints were ventricular stroke volume index (SVI) and myocardial mass index (MMI) as determined by Magnetic Resonance Imaging. The Intention to treat (ITT) principle was applied to analyze the summarized data set. Twenty-seven eligible men of the HIT-RT and 30 men of the HIIT group were included in the ITT. Both interventions significantly (p < 0.001) improve the MetS Z-Score, however the effect of HIIT was superior (p = 0.049). In parallel, HIT-RT and HIIT significantly affect SVI and MMI, with the effect of HIIT being much more pronounced (p < 0.001). Although HIIT endurance exercise was superior in favorably affecting cardiometabolic risk and particularly cardiac performance, both exercise methods positively affect cardiometabolic risk factors in this overweight to obese, middle-aged cohort of males with low time resources. Thus, the main practical application of our finding might be that in general overweight-obese people can freely choose their preferred exercise type (HIIT-END or HIT-RT) to improve their cardiometabolic health, while investing an amount of time that should be feasible for everybody. Trial Registrations: NCT01406730, NCT01766791.

Dataset Information

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.

Background

Methods

Discussion

Trial registration

Publications

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.

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