Breast CancerPACENCT06633380
Alternative Physical Activity Strategies for Breast Cancer Survivors
A study testing Standard Physical Activity - Fasted, Standard Physical Activity - Post-Meal and Dispersed Physical Activity in people with Breast Cancer and Insulin Resistance, run by University of Toronto at 1 site in Canada.
Trial summary
The primary aim of this study is to compare the acute glycemic effects of two novel, alternative physical activity (PA) strategies (dispersed post-meal PA, PA snacks) to a no PA condition and to exercise sessions representing the PA guidelines (standard 30-minute walking bout performed under fasting and under… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Insulin Resistance, Cardiometabolic Risk Factors
- What is being tested?
- Standard Physical Activity - Fasted, Standard Physical Activity - Post-Meal and Dispersed Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2024to 1 Jul 2026
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal biological females diagnosed with stage I, II, or III breast cancer and currently using aromatase inhibitors (AI) for at least 3 months prior to start of study participation
- All participants must meet the following criteria:
- Body mass index equal to or greater than 25 kg/m^2.
- Self-report consuming three main meals daily.
- Self-report as being sedentary (i.e., less than 30 minutes/week of moderate-to-vigorous aerobic physical activity and less than twice/week muscle strengthening of major muscle groups in the last three months.
Who cannot join
- If unable or unwilling to receive medical clearance by a physician after being screened for major signs or symptoms of cardiovascular diseases, diabetes, or renal disease and safety to initiate exercise.
- Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease are taken from the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription 11th edition Table 2.1. They include pain or discomfort in the chest, neck, jaw, arms with rest or exercise, shortness of breath at rest or with mild exertion, dizziness or syncope, ankle edema, palpitations or tachycardia, intermittent claudication, known heart murmur, and unusual fatigue with usual activities.
- Safety to initiate exercise will be screened using the Get Active Questionnaire, which is the Canadian Society of Exercise Physiology's endorsed evidence-based pre-screening tool.
- Using drugs for diabetes management (e.g., exogenous insulin, Ozempic, metformin, etc.) or actively losing weight (i.e., >5 kg weight loss in past 3 months) from drugs or other reasons
- Report any injury or other reason for not feeling capable of completing a 30 minute continuous walk or muscle strengthening exercise
- Unable to access an Ontario Lifelabs location for an overnight fasted blood draw
- Do not have a smartphone compatible with the applications required to collect data.
- Cannot read and understand the consent form or communicate in English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Remote Ontario-wide
Toronto, Ontario
Amy A Kirkham, PhD
About this study
Official title: Alternative Physical Activity Strategies for Breast and Prostate Cancer Survivors
The primary aim of this study is to compare the acute glycemic effects of two novel, alternative physical activity (PA) strategies (dispersed post-meal PA, PA snacks) to a no PA condition and to exercise sessions representing the PA guidelines (standard 30-minute walking bout performed under fasting and under postprandial conditions and a standard 30-minute resistance training session) among sedentary breast cancer survivors who are currently receiving hormone therapies and age- and BMI-matched postmenopausal women without a history of cancer. The secondary aim is to determine whether the alternative PA strategies are acceptable and feasible in the free-living setting. An exploratory aim is to determine whether the outcomes differ between women with and without a history of breast cancer and use of aromatase inhibitors.
The investigators hypothesize that:
- Dispersed PA and PA snacks will result in greater reductions in 24-hour glucose and postprandial glucose compared to the no-PA baseline and similar reductions to a standard 30-minute bouts of walking;
- The alternative PA strategies will be more feasible and have greater acceptability by cancer survivors compared to the standard 30-minute bout of walking or resistance training; and
- The different PA strategies will have similar effects on glycemic outcomes for both breast cancer survivors and cancer-free controls. The resistance exercise session is an exploratory trial as the effects of it on acute glycemic control are understudied.
- Being tested
- Standard Physical Activity - Fasted, Standard Physical Activity - Post-Meal, Dispersed Physical Activity, Physical Activity Snacks, Muscle Strengthening
- Keywords
- Physical Activity, Hormone Therapy, Glycemic Control
- Medical subject headings
- Breast Neoplasms, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physical Activity - FastedBehavioural
30 minutes of walking at a self-selected pace that they must have completed 15 minutes prior to consumption of first meal in the morning.
Standard Physical Activity - Post-MealBehavioural
30 minutes of walking at a self-selected pace to start 30 minutes after the start of the first meal in the morning.
Dispersed Physical ActivityBehavioural
10 minutes of walking at a self-selected pace to start 30 minutes after the start of each main meal throughout the day (i.e., three bouts total).
Physical Activity SnacksBehavioural
2 minutes of walking or marching on the spot at a self-selected pace every 30 minutes throughout the day for 7.5 waking hours.
Muscle StrengtheningBehavioural
30 minutes of muscle strengthening exercises targeting the major muscle groups of the whole body, to start 30 minutes after the start of the first meal in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Standard Physical Activity - Fasted | Experimental | Participants will perform 30 minutes of walking at a self-selected pace 15 minutes prior to consumption of first meal in the morning (including cream/sugar/milk in coffee or tea). Receives: Behavioral: Standard Physical Activity - Fasted |
| Standard Physical Activity - Post-Meal | Experimental | Participants will perform 30 minutes of walking at a self-selected pace 30 minutes after the start of the first meal in the morning. Receives: Behavioral: Standard Physical Activity - Post-Meal |
| Dispersed Physical Activity | Experimental | Participants will perform 10 minutes of walking at a self-selected pace 30 minutes after the start of each main meal throughout the day (i.e., three bouts total). Receives: Behavioral: Dispersed Physical Activity |
| Physical Activity Snacks | Experimental | Participants will perform 2 minutes of walking or marching on the spot at a self-selected pace every 30 minutes throughout the day for 7.5 waking hours. Receives: Behavioral: Physical Activity Snacks |
| Muscle Strengthening | Experimental | Participants will perform 30 minutes of muscle strengthening exercises targeting the major muscle groups of the whole body performed by following along with a video, to start 30 minutes after the start of the first meal in the morning. Receives: Behavioral: Muscle Strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour glucose incremental area under the curve (iAUC)
Assessed for each single-day intervention using a continuous glucose monitor from 8:00 am to the intervention day to 8:00 am the following morning.
Measured: Baseline, 24 hours of each intervention day
Secondary outcomes (10)
24-hour mean glucose
Assessed for each single-day intervention using a continuous glucose monitor from 8:00 am to the intervention day to 8:00 am the following morning.
Measured: Baseline, 24 hours of each intervention day
Postprandial iAUC
Assessed for each single-day intervention using a continuous glucose monitor for two hours following each meal.
Measured: Baseline, 24 hours of each intervention day
Peak postprandial glucose
Assessed as the highest glucose concentration during the 2 hours following each meal using a continuous glucose monitor.
Measured: Baseline, 24 hours of each intervention day
Daytime glucose concentration
Assessed for each single-day intervention using a continuous glucose monitor from 6:00 am to 12:00 am on the intervention day.
Measured: Baseline, 24 hours of each intervention day
Nocturnal glucose concentration
Assessed for each single-day intervention using a continuous glucose monitor from 12:00 am to 6:00 am on the intervention day.
Measured: Baseline, 24 hours of each intervention day
Time in hypoglycemia
Assessed as the number of hours with glucose less than 3.9 mmol/L using a continuous glucose monitor.
Measured: Baseline, 24 hours of each intervention day
Time in hyperglycemia
Assessed as the number of hours with glucose greater than 10 mmol/L using a continuous glucose monitor.
Measured: Baseline, 24 hours of each intervention day
Indices of glycemic variability
Indices include standard deviation, coefficient of variation, mean amplitude of glycemic excursion, and continuous overall net glycemic action
Measured: Baseline, 24 hours of each intervention day
Participant acceptability
Acceptability related to participants' experience with each single-day intervention will be assessed using a researcher-developed questionnaire at the end of each intervention day. Seven items use a 5-point Likert scale with responses ranging from "Strongly Disagree" to "Strongly Agree", while four items ask about participant confidence with responses ranging from 0 ("Not Confident") to 10 ("Very Confident). A higher total score indicates the intervention is more acceptable to the participant.
Measured: 24 hours of each intervention day
Participant enjoyment
Enjoyment related to participants' experience with each single-day intervention will be assessed using the short form of the Physical Activity Enjoyment Scale at the end of each intervention day, consisting of 8 items each scored on a 7-point Likert scale, with the total score ranging from 8 to 56, and a higher total score indicating greater enjoyment.
Measured: 24 hours of each intervention day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start22 Oct 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Crossover
- Model description
- 5-arm randomized crossover trial
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Kirkham, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633380
- Sponsor's protocol ID
- REB #44269
- Acronym
- PACE
- Status last verified
- Nov 2025
- First submitted
- 13 Sep 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Physical Activity Strategies for Breast and Prostate Cancer Survivors
- ClinicalTrials.gov ID
- NCT06633380
- Acronym / sponsor ID
- PACE / REB #44269
- Keywords
- Physical Activity, Hormone Therapy, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Oct 2024 (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.
The primary aim of this study is to compare the acute glycemic effects of two novel, alternative physical activity (PA) strategies (dispersed post-meal PA, PA snacks) to a no PA condition and to exercise sessions representing the PA guidelines (standard 30-minute walking bout performed under fasting and under postprandial conditions and a standard 30-minute resistance training session) among sedentary breast cancer survivors who are currently receiving hormone therapies and age- and BMI-matched postmenopausal women without a history of cancer. The secondary aim is to determine whether the alternative PA strategies are acceptable and feasible in the free-living setting. An exploratory aim is to determine whether the outcomes differ between women with and without a history of breast cancer and use of aromatase inhibitors.
The investigators hypothesize that:
- Dispersed PA and PA snacks will result in greater reductions in 24-hour glucose and postprandial glucose compared to the no-PA baseline and similar reductions to a standard 30-minute bouts of walking;
- The alternative PA strategies will be more feasible and have greater acceptability by cancer survivors compared to the standard 30-minute bout of walking or resistance training; and
- The different PA strategies will have similar effects on glycemic outcomes for both breast cancer survivors and cancer-free controls. The resistance exercise session is an exploratory trial as the effects of it on acute glycemic control are understudied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 5-arm randomized crossover trial
| Arm | Type | Receives |
|---|---|---|
| Standard Physical Activity - Fasted | Experimental | Behavioral: Standard Physical Activity - FastedParticipants will perform 30 minutes of walking at a self-selected pace 15 minutes prior to consumption of first meal in the morning (including cream/sugar/milk in coffee or tea). |
| Standard Physical Activity - Post-Meal | Experimental | Behavioral: Standard Physical Activity - Post-MealParticipants will perform 30 minutes of walking at a self-selected pace 30 minutes after the start of the first meal in the morning. |
| Dispersed Physical Activity | Experimental | Behavioral: Dispersed Physical ActivityParticipants will perform 10 minutes of walking at a self-selected pace 30 minutes after the start of each main meal throughout the day (i.e., three bouts total). |
| Physical Activity Snacks | Experimental | Behavioral: Physical Activity SnacksParticipants will perform 2 minutes of walking or marching on the spot at a self-selected pace every 30 minutes throughout the day for 7.5 waking hours. |
| Muscle Strengthening | Experimental | Behavioral: Muscle StrengtheningParticipants will perform 30 minutes of muscle strengthening exercises targeting the major muscle groups of the whole body performed by following along with a video, to start 30 minutes after the start of the first meal in the morning. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal biological females diagnosed with stage I, II, or III breast cancer and currently using aromatase inhibitors (AI) for at least 3 months prior to start of study participation
- All participants must meet the following criteria:
Key exclusion criteria (8 listed)
- If unable or unwilling to receive medical clearance by a physician after being screened for major signs or symptoms of cardiovascular diseases, diabetes, or renal disease and safety to initiate exercise.
- Using drugs for diabetes management (e.g., exogenous insulin, Ozempic, metformin, etc.) or actively losing weight (i.e., >5 kg weight loss in past 3 months) from drugs or other reasons
- Report any injury or other reason for not feeling capable of completing a 30 minute continuous walk or muscle strengthening exercise
- Unable to access an Ontario Lifelabs location for an overnight fasted blood draw
- Do not have a smartphone compatible with the applications required to collect data.
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 |
|---|---|---|
| Standard Physical Activity - Fasted30 minutes of walking at a self-selected pace that they must have completed 15 minutes prior to consumption of first meal in the morning. | Behavioural | Standard Physical Activity - Fasted |
| Standard Physical Activity - Post-Meal30 minutes of walking at a self-selected pace to start 30 minutes after the start of the first meal in the morning. | Behavioural | Standard Physical Activity - Post-Meal |
| Dispersed Physical Activity10 minutes of walking at a self-selected pace to start 30 minutes after the start of each main meal throughout the day (i.e., three bouts total). | Behavioural | Dispersed Physical Activity |
| Physical Activity Snacks2 minutes of walking or marching on the spot at a self-selected pace every 30 minutes throughout the day for 7.5 waking hours. | Behavioural | Physical Activity Snacks |
| Muscle Strengthening30 minutes of muscle strengthening exercises targeting the major muscle groups of the whole body, to start 30 minutes after the start of the first meal in the morning. | Behavioural | Muscle Strengthening |
Primary outcome
24-hour glucose incremental area under the curve (iAUC)
Time frame: Baseline, 24 hours of each intervention day
Assessed for each single-day intervention using a continuous glucose monitor from 8:00 am to the intervention day to 8:00 am the following morning.
10 secondary outcomes
24-hour mean glucose
Time frame: Baseline, 24 hours of each intervention day
Postprandial iAUC
Time frame: Baseline, 24 hours of each intervention day
Peak postprandial glucose
Time frame: Baseline, 24 hours of each intervention day
Daytime glucose concentration
Time frame: Baseline, 24 hours of each intervention day
Nocturnal glucose concentration
Time frame: Baseline, 24 hours of each intervention day
Time in hypoglycemia
Time frame: Baseline, 24 hours of each intervention day
Time in hyperglycemia
Time frame: Baseline, 24 hours of each intervention day
Indices of glycemic variability
Time frame: Baseline, 24 hours of each intervention day
Participant acceptability
Time frame: 24 hours of each intervention day
Participant enjoyment
Time frame: 24 hours of each intervention day
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 2 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Physical Activity - Fasted, Standard Physical Activity - Post-Meal and Dispersed Physical Activity in people with Breast Cancer and Insulin Resistance, run by University of Toronto at 1 site 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 5 inclusion and 8 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 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Amy A Kirkham, PhD (416-946-4069, amy.kirkham@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour glucose incremental area under the curve (iAUC) (time frame: Baseline, 24 hours of each intervention day). 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 2 Dec 2025.