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New treatment option for Metabolic Disturbance
Official title Multiple Risk Factor Intervention Trial in Breast Cancer Survivors
ClinicalTrials.gov ID: NCT06454864
What this study is testing
- What it's testing
- This study aims to produce new evidence on the efficacy of exercise and diet for cardiometabolic risk reduction in BC survivors. Using a 3-arm RCT with to 6 months of 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions: What is the impact of exercise on cardiometabolic health and body composition in BC survivors?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only
You may be able to join if
- Biologically female
- Diagnosis of stage I, II, or III breast cancer, post-menopausal at the time of diagnosis (haven't had a menstrual cycle within 12 months or greater)
- Receipt of aromatase inhibitors for 12 months or more in the past, but do not have to be currently on aromatase inhibitors.
- Willing and able to complete all study assessments
- BMI ≥ 25 kg/m2
You likely can't join if
- Received chemotherapy within the past 11 months
- Diagnosed with metastatic cancer
- Currently taking tamoxifen
- Currently receiving chemotherapy, targeted therapy or radiation treatment
- Distant recurrence or diagnosis of metastatic cancer since early-stage breast cancer diagnosis
- Diagnosed cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, uncontrolled thyroid condition, or respiratory disease (e.g...
See the full eligibility criteria
- Biologically female
- Diagnosis of stage I, II, or III breast cancer, post-menopausal at the time of diagnosis (haven't had a menstrual cycle within 12 months or greater)
- Receipt of aromatase inhibitors for 12 months or more in the past, but do not have to be currently on aromatase inhibitors.
- Willing and able to complete all study assessments
- BMI ≥ 25 kg/m2
- Able to commit to come to the University once per week for 24 weeks.
- Received chemotherapy within the past 11 months
- Diagnosed with metastatic cancer
- Currently taking tamoxifen
- Currently receiving chemotherapy, targeted therapy or radiation treatment
- Distant recurrence or diagnosis of metastatic cancer since early-stage breast cancer diagnosis
- Diagnosed cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, uncontrolled thyroid condition, or respiratory disease (e.g., COPD or severe or uncontrolled asthma).
- Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (taken from the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription 11th edition Table 2.1: pain or...
- American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing (myocardial infarction, aortic or coronary artery stenosis, heart failure, pulmonary embolism or deep vein...
- Unable to provide informed consent or communicate in English
- Pregnant or breast-feeding currently or in the past 3 months
- Mobility limitations to aerobic exercise (i.e., wheelchair, walker use, limp impeding walking)
- Smoking cigarettes or marijuana within the past 3 months
- Taking exogenous hormones in any format currently or in the past 3 months
- Contraindications to research MRI (e.g., pacemaker, magnetic implants)
- BMI exceeding 40 kg/m2
- Extreme claustrophobia
- Self-report \>30 min/week of moderate-to-vigorous intensity aerobic physical activity
- Following a diet that largely restricts entire food groups or time of eating (e.g., vegan, ketogenic, carnivore, one meal a day) in last 3 months
- Experienced significant weight loss (i.e., \>5 kg) in past 3 months
- Currently taking weight loss medications
- Diagnosed history of an eating disorder or self-report of potential undiagnosed eating disorder
- Plans to be away/unavailable for a substantial period of the intervention overall (i.e., \>4 weeks throughout the 6 months or \>2 weeks within the first 12 weeks of the intervention).
- Allergies to local anesthetics
The study team makes the final eligibility decision.
Where it's taking place
- 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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.