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Official title Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women
ClinicalTrials.gov ID: NCT05432856
What this study is testing
- What it's testing
- 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 rates have decreased by 48% over the past 30 years as a result of advances in prevention, detection, and treatment.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female biological sex at birth
- \>18 years
- Diagnosis of stage I, II, or III breast cancer
- starting neoadjuvant or adjuvant intravenous chemotherapy
- ECOG \<3;
You likely can't join if
- Individuals who do not have access to a smart phone with Bluetooth capability (required for Fitbit and for responding to intervention text messages)...
- 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)
See the full eligibility 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.