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Clinical Trials in Canada / NCT04616300
Recruiting Observational

Exercise and Cognitive (Brain) Function in Breast Cancer Patients Getting Chemotherapy After Breast Surgery

NCT04616300 · tracked via the Priya Life Science Canada tracker
Sponsor
University of Toronto
Phase
Observational
Started
2019-12-12
Last updated
2024-12-06

Condition(s) studied

Breast Cancer

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 outcome measure(s)

  • Fluid Cognition (Composite) — Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
    Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). This composite includes all the tests noted above that are fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the normalized scores of each of the measures, and then deriving scale scores based on this new distribution. An Age-Adjusted Scale Score, Fully Adjusted Scale Score, Unadjusted Scale Score and Age-Adjusted National Percentile are provided for the Fluid Cognition Composite. The Fluid Cognition Composite is a more global assessment of individual and group fluid cognition functioning. Higher scores indicate higher levels of functioning.

Trial sites (1)

FacilityCityRegionStatus
Sunnybrook Health Sciences Centre-Odette Cancer Centre Toronto Ontario Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04616300 on ClinicalTrials.gov ↗ ← All trials in Canada