Cardiovascular DiseasesIMPACT-WomenNCT05432856
Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women
A study testing Time restricted eating, nutrition education, and sedentary time reduction strategies in people with Cardiovascular Diseases and Cardiovascular Morbidity, run by University of Alberta at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Morbidity, Metabolic Disease
- What is being tested?
- Time restricted eating, nutrition education, and sedentary time reduction strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Mar 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- ≥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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G2R3
Rachel Sherrington, Bkin, 780-668-1669, rsherrin@ualberta.ca
Richard Thrompson, PhD
- Recruiting
University of Toronto
Toronto, Ontario
Mirey Karavetian, PhD, mirey.karavetian@utoronto.ca
Amy Kirkham, PhD
About this study
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. However, competing risks for mortality from non-cancer causes have emerged, where cardiovascular disease (CVD) is now a leading cause of death for BC survivors. The direct toxic effects of BC treatment on the heart (cardiotoxicity) are well characterized by the investigators and many others, as a contributor to elevated cardiovascular risk. However, BC treatment and the associated lifestyle changes (i.e. physical inactivity, poor diet quality, stress) are increasingly recognized to also strongly affect metabolism negatively manifesting as insulin resistance, dyslipidemia and adipose tissue (fat) accumulation. These adverse metabolic changes are strongly linked to CVD risk and represent a currently underappreciated contributor to the elevated CVD risk among BC survivors. Preliminary data and recent publications demonstrate that regional fat accumulation occurs during BC treatment and that the fat burden in key locations is associated with poor cardiorespiratory health. A trigger of these adverse metabolic and inflammatory effects is excess fat specifically within ectopic fat (viscera, intermuscular, or hepatic) regions. In 2019, a member of the study team found that the volume of visceral and intermuscular but not subcutaneous fat at BC diagnosis were linearly associated with CVD events within 6 years, even among those with normal BMI and after adjustment for pre-existing CVD risk factors and for BC treatment type. Using MRI, investigators found that ~1 year after chemotherapy, BC survivors had significantly larger depots of visceral fat (49% larger) and thigh intermuscular fat (41% larger) compared to age and sex-matched controls, despite similar BMI and subcutaneous fat volumes in the two groups. Investigators also showed that the fat fraction within the thigh muscle and visceral fat volumes independently explained ~50% of the variation in cardiorespiratory fitness (measured by peak VO2). In particular, peak VO2 is one of the most powerful predictors of all-cause and CVD mortality and health care costs, and is the most consistently reported negative sequelae after treatment for BC. Unfortunately, there are no known therapies to recover long-term myocardial damage (i.e. cell death, fibrosis) from cancer therapies. There are several reasons to target fat as a therapeutic target in BC patients: 1) The study team have compelling preliminary data showing accelerated formation of ectopic fat during BC treatment. 2) Investigator's recent data showed that high fat content in key fat pools was associated with reduced peak VO2. 3) The burden of fat and the associated metabolic abnormalities are dynamic and malleable, and thus highly treatable.
Read more
Research Question \& Objectives:
The primary purpose of this study is to evaluate the effect of a behavioural intervention involving supported time-restricted eating (TRE), diet quality improvements, and reduced sedentary time versus usual cancer and nutrition care in BC patients receiving chemotherapy treatment on ectopic fat, cardiometabolic profile, and chemotherapy outcomes. The investigators hypothesize that the intervention will attenuate the growth of ectopic fat during chemotherapy and reduce chemotherapy symptoms.
- Being tested
- Time restricted eating, nutrition education, and sedentary time reduction strategies
- Medical subject headings
- Cardiovascular Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eating, nutrition education, and sedentary time reduction strategiesBehavioural
- TRE: You will be asked to eating as much as you like but only within an 8-10 hour window and then do not eat, or "fast" by consuming only water, black coffee or tea without milk/sugar for a window of 16 hours per day. This protocol will be required for 5 or more days in a row each week.
- Nutrition education and individualized recommendations: You will receive an assessment, and one-on-one education on healthy eating according to Canada's dietary guidelines, with individualized small goal each to improve your dietary habits.
- Sedentary time reduction: Using the provided Fitbit wrist monitor, you will be asked to track and gradually increase your daily step counts, break up periods of inactivity, and try to incorporate ways to decrease sedentary behaviour in everyday life.
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted Eating and Sedentary Time Reduction | Experimental | Group 1 (Experimental intervention): Participants assigned to this group will receive standard chemotherapy treatment plus a dietary program, and sedentary time reduction strategies, program and a Fitbit monitor. If you are randomized into this group, you will be asked to follow TRE, will receive nutritional education and individualized recommendations on improving diet quality and healthy eating practices, and given to strategies to work towards reducing sedentary time. These components will be gradually introduced over the 24-week program. Receives: Behavioral: Time restricted eating, nutrition education, and sedentary time reduction strategies |
| Nutrition and Exercise Guidelines | No intervention | Group 2 (Non-experimental intervention): Participants randomized to this group will receive standard chemotherapy treatment plus a single, group-based "nutrition during cancer" class, as well as a copy of Canada's Food Guide, physical activity guidelines, and a Fitbit monitor. You will be asked to only make dietary changes if they are recommended within the class or by your doctor, and to maintain your usual timing and number of meals consumed per day. Throughout the 24-week period, you will receive seven brief phone calls from a study staff member to ask about your symptoms and provide support. After the end of the study, participants in this group will be offered a one-one-one counselling session with a registered dietitian. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Volumes
Visceral fat volumes as measured by MRI.
Measured: Baseline, 24-weeks, and 2 years
Secondary outcomes (6)
Change in Thigh Fat Pool Volume
Thigh intermuscular and intramuscular fat volumes as measured by MRI.
Measured: Baseline, 24-weeks, and 2 years
Change in Liver Fat Volume
Volume of fat in the hepatocytes in the liver as measured by MRI.
Measured: Baseline, 24-weeks, and 2 years
Change in Subcutaneous Abdominal Fat Volume
Subcutaneous fat volumes that surround the abdomen as measured by MRI.
Measured: Baseline, 24-weeks, and 2 years
Change in Metabolic Syndrome Z-score
Defined by the National Cholesterol Education Program Adult Treatment Panel, metabolic syndrome is determined by the presence of 3 or more of the following: abdominal obesity defined by waist circumference (men >102cm, women >88cm), triglycerides ≥150mg/dL, fasting glucose ≥110mg/dL, HDL cholesterol <40mg/dL for men and <50mg/dL for women, and blood pressure of ≥130/≥85mmHg. Z-scores of 0 are equal to the mean. Anything above 0 for each risk listed above (excluding HDL cholesterol) indicates higher risk of CVD. Since HDL cholesterol is healthy, higher z-scores indicate lower risk of CVD. Z-scores rarely fall outside a range of -3 to 3.
Measured: Baseline, 24-weeks, and 2 years
Change in Framingham risk score
Using the Framingham risk score to determine cardiovascular disease risk calculated using the Canadian Cardiovascular Society scoring system for age, sex, total cholesterol (mg/dL), high-density lipoprotein (mg/dL), treated or untreated systolic blood pressure (mmHg), diabetes, and smoking status (self-reported in questionnaires). Each category listed above is also assigned a numeric value. To find risk, one must total their points together from each category. The minimum value ranges from -3 or less points to a maximum value range of 21+ points. -3 or less points indicates a very low risk of cardiovascular disease, and 21+ points indicates a high risk of cardiovascular disease.
Measured: Baseline, 24-weeks, and 2 years
Change in Peak VO2
Maximal amount of oxygen consumed during a cardiopulmonary exercise test on a cycle ergometer measured by mL/kg/min to indicate cardiorespiratory fitness.
Measured: Baseline, 24-weeks, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start13 Mar 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Richard Thompson, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432856
- Sponsor's protocol ID
- HREBA.CC-22-0128
- Acronym
- IMPACT-Women
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2022
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information collected during the study will be used in analyses and will be published/ presented to the scientific community at meetings and in journals. In addition, study data without any identifying information will be shared with the research team at the University of Toronto, where the study is also taking place.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women
- ClinicalTrials.gov ID
- NCT05432856
- Acronym / sponsor ID
- IMPACT-Women / HREBA.CC-22-0128
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. However, competing risks for mortality from non-cancer causes have emerged, where cardiovascular disease (CVD) is now a leading cause of death for BC survivors. The direct toxic effects of BC treatment on the heart (cardiotoxicity) are well characterized by the investigators and many others, as a contributor to elevated cardiovascular risk. However, BC treatment and the associated lifestyle changes (i.e. physical inactivity, poor diet quality, stress) are increasingly recognized to also strongly affect metabolism negatively manifesting as insulin resistance, dyslipidemia and adipose tissue (fat) accumulation. These adverse metabolic changes are strongly linked to CVD risk and represent a currently underappreciated contributor to the elevated CVD risk among BC survivors. Preliminary data and recent publications demonstrate that regional fat accumulation occurs during BC treatment and that the fat burden in key locations is associated with poor cardiorespiratory health. A trigger of these adverse metabolic and inflammatory effects is excess fat specifically within ectopic fat (viscera, intermuscular, or hepatic) regions. In 2019, a member of the study team found that the volume of visceral and intermuscular but not subcutaneous fat at BC diagnosis were linearly associated with CVD events within 6 years, even among those with normal BMI and after adjustment for pre-existing CVD risk factors and for BC treatment type. Using MRI, investigators found that ~1 year after chemotherapy, BC survivors had significantly larger depots of visceral fat (49% larger) and thigh intermuscular fat (41% larger) compared to age and sex-matched controls, despite similar BMI and subcutaneous fat volumes in the two groups. Investigators also showed that the fat fraction within the thigh muscle and visceral fat volumes independently explained ~50% of the variation in cardiorespiratory fitness (measured by peak VO2). In particular, peak VO2 is one of the most powerful predictors of all-cause and CVD mortality and health care costs, and is the most consistently reported negative sequelae after treatment for BC. Unfortunately, there are no known therapies to recover long-term myocardial damage (i.e. cell death, fibrosis) from cancer therapies. There are several reasons to target fat as a therapeutic target in BC patients: 1) The study team have compelling preliminary data showing accelerated formation of ectopic fat during BC treatment. 2) Investigator's recent data showed that high fat content in key fat pools was associated with reduced peak VO2. 3) The burden of fat and the associated metabolic abnormalities are dynamic and malleable, and thus highly treatable.
Research Question \& Objectives:
The primary purpose of this study is to evaluate the effect of a behavioural intervention involving supported time-restricted eating (TRE), diet quality improvements, and reduced sedentary time versus usual cancer and nutrition care in BC patients receiving chemotherapy treatment on ectopic fat, cardiometabolic profile, and chemotherapy outcomes. The investigators hypothesize that the intervention will attenuate the growth of ectopic fat during chemotherapy and reduce chemotherapy symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-Restricted Eating and Sedentary Time Reduction | Experimental | Behavioral: Time restricted eating, nutrition education, and sedentary time reduction strategiesGroup 1 (Experimental intervention): Participants assigned to this group will receive standard chemotherapy treatment plus a dietary program, and sedentary time reduction strategies, program and a Fitbit monitor. If you are randomized into this group, you will be asked to follow TRE, will receive nutritional education and individualized recommendations on improving diet quality and healthy eating practices, and given to strategies to work towards reducing sedentary time. These components will be gradually introduced over the 24-week program. |
| Nutrition and Exercise Guidelines | No intervention | –Group 2 (Non-experimental intervention): Participants randomized to this group will receive standard chemotherapy treatment plus a single, group-based "nutrition during cancer" class, as well as a copy of Canada's Food Guide, physical activity guidelines, and a Fitbit monitor. You will be asked to only make dietary changes if they are recommended within the class or by your doctor, and to maintain your usual timing and number of meals consumed per day. Throughout the 24-week period, you will receive seven brief phone calls from a study staff member to ask about your symptoms and provide support. After the end of the study, participants in this group will be offered a one-one-one counselling session with a registered dietitian. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female biological sex at birth
- >18 years
- Diagnosis of stage I, II, or III breast cancer
- starting neoadjuvant or adjuvant intravenous chemotherapy
- ECOG <3;
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eating, nutrition education, and sedentary time reduction strategies1. TRE: You will be asked to eating as much as you like but only within an 8-10 hour window and then do not eat, or "fast" by consuming only water, black coffee or tea without milk/sugar for a window of 16 hours per day. This protocol will be required for 5 or more days in a row each week. 2. Nutrition education and individualized recommendations: You will receive an assessment, and one-on-one education on healthy eating according to Canada's dietary guidelines, with individualized small goal each to improve your dietary habits. 3. Sedentary time reduction: Using the provided Fitbit wrist monitor, you will be asked to track and gradually increase your daily step counts, break up periods of inactivity, and try to incorporate ways to decrease sedentary behaviour in everyday life. | Behavioural | Time-Restricted Eating and Sedentary Time Reduction |
Primary outcome
Change in Fat Volumes
Time frame: Baseline, 24-weeks, and 2 years
Visceral fat volumes as measured by MRI.
6 secondary outcomes
Change in Thigh Fat Pool Volume
Time frame: Baseline, 24-weeks, and 2 years
Change in Liver Fat Volume
Time frame: Baseline, 24-weeks, and 2 years
Change in Subcutaneous Abdominal Fat Volume
Time frame: Baseline, 24-weeks, and 2 years
Change in Metabolic Syndrome Z-score
Time frame: Baseline, 24-weeks, and 2 years
Change in Framingham risk score
Time frame: Baseline, 24-weeks, and 2 years
Change in Peak VO2
Time frame: Baseline, 24-weeks, and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. Information collected during the study will be used in analyses and will be published/ presented to the scientific community at meetings and in journals. In addition, study data without any identifying information will be shared with the research team at the University of Toronto, where the study is also taking place.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Thompson, PhD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating, nutrition education, and sedentary time reduction strategies in people with Cardiovascular Diseases and Cardiovascular Morbidity, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Sherrington, Bkin (780-668-1669, rsherrin@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fat Volumes (time frame: Baseline, 24-weeks, and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.