Effects of metabolic health patterns on breast cancer outcomes in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of metabolic health patterns on breast cancer outcomes over time in women undergoing chemotherapy. It focuses on the relationship between breast cancer treatment, cardiovascular disease risk, and metabolic changes such as insulin resistance and dyslipidemia. Participants will engage in interventions including time-restricted eating, nutrition education, and strategies to reduce sedentary time. The goal is to understand how these interventions can improve metabolic health and reduce cardiovascular risks in breast cancer survivors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting
• University of Toronto
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Richard Thompson, PhD — University of Alberta
• Study coordinator: Rachel Sherrington, Bkin
• Email: rsherrin@ualberta.ca
• Phone: 780-668-1669

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.