Effects of metabolic health patterns on breast cancer outcomes in women

Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women

This study is testing whether improving metabolic health through diet and activity changes can help women with breast cancer feel better and reduce their heart disease risk during and after chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Alberta (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Edmonton, Alberta and 1 other locations)
• Trial ID: NCT05432856 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old, diagnosed with stage I, II, or III breast cancer, and starting chemotherapy.

Not a fit: Patients with uncontrolled diabetes requiring insulin, significant thyroid disorders, or a history of eating disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved metabolic health and reduced cardiovascular risks for women undergoing treatment for breast cancer.

How similar studies have performed: Other studies have shown promising results in improving metabolic health and reducing cardiovascular risks in cancer survivors through lifestyle interventions.

Eligibility criteria

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 this trial is running

Edmonton, Alberta and 1 other locations

• 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

Conditions Cardiovascular Diseases; Cardiovascular Morbidity; Metabolic Disease