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

NCT04616300 | Recruiting

• 1 other identifier: 38406
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

cardiorespiratory fitness; cognitive function; physical activity; chemotherapy treatment; cancer biomarkers

Outcome Measures

Primary Outcomes (1)

• Fluid Cognition (Composite)

  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.

  Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).

Secondary Outcomes (14)

• Executive/Attention

  Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).

• Executive/Shifting

  Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).

• Working Memory

  Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).

• Episodic Memory

  Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).

• Language (oral reading)

  Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 BCS from the Odette Cancer Centre and breast cancer organizations within the Greater Toronto Area

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Sunnybrook Health Sciences Centre-Odette Cancer Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Central Study Contacts

Linda Trinh, PhD

CONTACT

(416) 946-3624; linda.trinh@utoronto.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 4, 2020
• Study Start: December 12, 2019
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)