Status:
RECRUITING
Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Cardiovascular Diseases
Cardiovascular Morbidity
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Background \& Rationale: Breast cancer (BC) is the most commonly diagnosed malignancy in women worldwide (2.1 million diagnoses in 2018, 25% of new cancer cases). In Canada, early stage BC mortality ...
Eligibility Criteria
Inclusion
- Female biological sex at birth
- \>18 years
- Diagnosis of stage I, II, or III breast cancer
- starting neoadjuvant or adjuvant intravenous chemotherapy
- ECOG \<3;
- Oncologist approval to participate;
- English speaking (all study materials and study staff will be in English)
- Willing and able to adhere to study intervention
Exclusion
- Individuals who do not have access to a smart phone with Bluetooth capability (required for Fitbit and for responding to intervention text messages) or at least a shared cell phone with someone in the same household (i.e., some couples may share a phone).
- Type 1 or type 2 diabetes who require exogenous insulin (due to the potential need to adjust insulin dosing with TRE) or with hemoglobin A1c \>10%
- Research MRI contraindications (e.g., pacemaker, magnetic implants, pregnancy)
- Uncontrolled thyroid disorder
- Self-reported eating disorder history
- Body mass index \<18.5 kg/m2 or clinical signs of cachexia (discretion of treating oncologist)
- ≥5% body weight loss within last 6 months
- Those who are currently working night/rotating shifts, eating within ≤10-hour window or consistently eating less than 3 meals/day in the past 3 months.
- patients who meet the criteria for medical clearance prior to exercise using the Physical Activity Readiness Questionnaire+ and are not cleared by their treating oncologist or family physician to perform maximal exercise testing.
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05432856
Start Date
March 13 2024
End Date
June 1 2027
Last Update
August 27 2025
Active Locations (2)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G2R3
2
University of Toronto
Toronto, Ontario, Canada