Recruiting

Exercise with Chemotherapy

Sponsor:

University of Toronto

Code:

NCT04616300

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04616300

Start date

Dec 12, 2019

Status verified date

Dec, 2024

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Fluid Cognition (Composite) [ Time Frame: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3). ]

Central Contacts and Locations

Central contacts

Linda Trinh, PhD

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

Locations

Sunnybrook Health Sciences Centre-Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

More Information

Sponsor

University of Toronto

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2024-12-06.