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Search / Trial NCT05432856

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

Launched by UNIVERSITY OF ALBERTA · Jun 21, 2022

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how certain lifestyle changes can help women with breast cancer reduce fat accumulation and improve their heart health during chemotherapy. The researchers want to see if a program that includes time-restricted eating (a way of eating where you only eat during certain hours), improving diet quality, and reducing sitting time can help these women stay healthier while they undergo treatment. The hope is that these changes will lead to less harmful fat buildup in the body, which can help prevent heart problems later on.

To participate in this study, you must be a female over 18 years old who has been diagnosed with stage I, II, or III breast cancer and is about to start chemotherapy. You'll also need to be able to communicate in English and have the support of your oncologist. If you join, you can expect to receive guidance on nutrition and activity, and you'll be monitored throughout the trial. It's important to note that this study is currently looking for participants, and you will need access to a smartphone for some of the activities.

Gender

FEMALE

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.

About University Of Alberta

The University of Alberta, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials. With a strong commitment to scientific excellence and community health, the university facilitates cutting-edge research across various medical disciplines. Its interdisciplinary approach fosters collaboration among researchers, clinicians, and students, ensuring that clinical trials are designed and conducted with the utmost rigor and ethical standards. By leveraging its extensive resources and expertise, the University of Alberta aims to translate research findings into meaningful advancements in patient care and public health.

Locations

Toronto, Ontario, Canada

Edmonton, Alberta, Canada

Patients applied

0 patients applied

Trial Officials

Richard Thompson, PhD

Principal Investigator

University of Alberta

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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