Actively Recruiting
Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women
Led by University of Alberta · Updated on 2025-08-27
65
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Breast cancer is the most common cancer in women worldwide, with significant advances in treatment reducing mortality rates. However, cardiovascular disease has become a leading cause of death for breast cancer survivors due to the toxic effects of cancer treatments and lifestyle changes leading to harmful fat accumulation and metabolic problems. This study aims to evaluate whether a behavioral intervention involving time-restricted eating, improved diet, and reduced sedentary time can reduce harmful fat buildup and improve heart and metabolic health during chemotherapy for breast cancer patients. Participants will be randomly assigned to one of two groups. The experimental group will receive standard chemotherapy plus a 24-week program including time-restricted eating, personalized nutrition education, and strategies to reduce sedentary behavior, supported by a Fitbit monitor. The control group will receive standard chemotherapy and a single group-based nutrition class, along with general dietary and physical activity guidelines, Fitbit monitoring, and support calls. After the study, control group participants will be offered individualized dietitian counseling. Throughout the study, participants will be monitored at baseline, 24 weeks, and 2 years for changes in fat volumes in specific body areas using MRI, metabolic health scores, cardiovascular risk scores, and peak oxygen uptake (peak VO2) to assess heart and fitness levels. Researchers will track symptoms, diet, physical activity, and chemotherapy outcomes to understand the impact of the intervention on metabolism and cardiovascular health in breast cancer survivors.
CONDITIONS
Brief Title
Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female biological sex at birth
- Age over 18 years
- Diagnosis of stage I, II, or III breast cancer
- Starting neoadjuvant or adjuvant intravenous chemotherapy
- ECOG performance status less than 3
- Approval from oncologist to participate
- English speaking
- Willing and able to follow study intervention
You will not qualify if you...
- No access to a smartphone with Bluetooth or shared cell phone in the household
- Type 1 or type 2 diabetes requiring insulin or hemoglobin A1c over 10%
- Contraindications for MRI (e.g., pacemaker, magnetic implants, pregnancy)
- Uncontrolled thyroid disorder
- History of eating disorders
- Body mass index less than 18.5 kg/m2 or signs of cachexia
- Weight loss of 5% or more in the last 6 months
- Currently working night or rotating shifts
- Eating within 10-hour window or less than 3 meals per day consistently in past 3 months
- Not cleared for maximal exercise testing by oncologist or family physician if required by Physical Activity Readiness Questionnaire+ assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants assigned to the experimental group follow time-restricted eating, nutrition education, and sedentary time reduction strategies over a 24-week period. Participants in the non-experimental group receive standard chemotherapy plus a group nutrition class and ongoing support calls during this time.
Multiple visits including baseline, follow-up visits, and seven brief phone calls for support depending on group assignment
Duration - Up to 2 years after treatment
Participants have assessments to monitor changes in fat volumes and metabolic health at 2 years after treatment.
1 to 2 visits depending on assessment schedule
Trial Site Locations
Total: 2 locations
1
University of Alberta
Edmonton, Alberta, Canada, T6G2R3
Actively Recruiting
2
University of Toronto
Toronto, Ontario, Canada
Actively Recruiting
Research Team
R
Rachel Sherrington, Bkin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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