Clinical trial NCT04616300: Exercise and Cognitive (Brain) Function in Breast Cancer Patients Getting Chemotherapy After Breast Surgery
Official title: Cardiorespiratory Fitness, Inflammatory Biomarkers, and Cognitive Function Patterns During Treatment for Breast Cancer: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: cardiorespiratory fitness
cognitive function
physical activity
chemotherapy treatment
cancer biomarkers
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 BCS from the Odette Cancer Centre and breast cancer organizations within the Greater Toronto Area

Brief summary: This study will primarily identify longitudinal associations between cardiorespiratory fitness (CRF) and cognitive function pre- (baseline) to post-chemotherapy (\~3 months). This will be a prospective study of 50 BCS. We hypothesize that breast cancer patients undergoing chemotherapy who have higher levels of CRF at baseline will have significantly improved measures of attention, executive function, and memory post-chemotherapy. In addition, the exploratory aims will examine the longitudinal associations between physical activity (PA) and cognitive function from pre- to post-chemotherapy and explore the associations between inflammatory and non-inflammatory biomarkers and CRF with cognitive function.

Detailed description: Detailed Description:

Cognitive impairments are reported as a chief quality of life (QoL) complaint by approximately 75% of breast cancer survivors (BCS). Women who have undergone adjuvant chemotherapy are at the highest risk for cognitive impairments, that may affect BCS up to 20 years post-treatment.Despite the prevalence and significance, it is largely underdiagnosed and there are no proven treatments beyond symptom management. Several studies have assessed cognitive function in cancer populations. Increasing evidence highlights the role of lifestyle behaviours on cancer-related outcomes, ranging from QoL to prognosis. However, very few studies have examined the associations of lifestyle factors and cognitive function in BCS.One of the most important mediators of CRCI in BCS may be cardiorespiratory fitness (CRF).

Our overall objective is to examine the behavioral and biological mechanisms that contribute to cognitive decline in BCS undergoing chemotherapy using an epidemiologic, prospective cohort design.

Assessments taken at baseline (pre-chemotherapy) and post-chemotherapy (month 3). Cognitive Function will be assessed using the NIH toolbox cognition battery. Physical Activity. PA will be assessed by accelerometers and through self-report using the Godin-Leisure Time Exercise Questionnaire. Cardiorespiratory Fitness will be assessed using the 6-minute walk test to estimate maximum oxygen uptake (VO2max).Cancer Biomarkers will be assessed using venous blood (2 microtubes) will be drawn from the antecubital vein by a trained phlebotomist. Biological markers analyzed in blood will include a multiplex panel of inflammatory cytokines (i.e., IL1, IL6, TNFα), and brain-derived neurotrophic factor (BDNF).

Our proposed study will be instrumental in designing future targeted translational lifestyle interventions to improve cognitive health in BCS. In addition, understanding the trajectory of cognitive function as it relates to these factors will determine the opportune timeframe to intervene during the cancer care continuum for the greatest impact.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* histologically-confirmed stage I-III breast cancer, but prior to the initiation of chemotherapy (\<1 cycle of adjuvant therapy or neoadjuvant therapy)
* no diagnosed major cognitive disorders and uncontrolled comorbidities.

Exclusion Criteria:

* received neoadjuvant chemotherapy and scheduled to receive adjuvant chemotherapy
* scheduled to receive concurrent radiation therapy with chemotherapy.

Primary outcomes:
measure: Fluid Cognition (Composite)
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
Secondary outcomes:
measure: Executive/Attention
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Executive/Shifting
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Working Memory
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Episodic Memory
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Language (oral reading)
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Language (picture vocabulary)
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Processing Speed (Pattern comparison)
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Crystallized Cognition
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Immediate Recall
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Processing Speed (oral symbol digit test)
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Objectively-assessed physical activity
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Self-reported physical activity
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Cancer biomarkers
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
measure: Cardiorespiratory fitness
timeFrame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre-Odette Cancer Centre
state: Ontario
Study officials:
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