Clinical trial NCT06633380: Alternative Physical Activity Strategies for Breast and Prostate Cancer Survivors
Official title: Alternative Physical Activity Strategies for Breast and Prostate Cancer Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Insulin Resistance
Cardiometabolic Risk Factors
Keywords: Physical Activity
Hormone Therapy
Glycemic Control
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 5-arm randomized crossover trial
Primary purpose: PREVENTION

Brief 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 postprandial conditions and a standard 30-minute resistance training session) among sedentary survivors of breast and prostate cancer who are currently receiving hormone therapies. The secondary aim is to determine whether the alternative PA strategies are acceptable and feasible in the free-living setting. The exploratory aim is to determine whether these outcomes differ by cancer type.

The investigators hypothesize that:

1. 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;
2. 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
3. The different PA strategies will have similar effects on glycemic outcomes for both breast and prostate cancer survivors. The resistance exercise session is an exploratory trial as the effects of it on acute glycemic control are understudied.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal biological females diagnosed with stage I, II, or III breast cancer and currently using aromatase inhibitors (AI)
* Biological males diagnosed with stage I, II, or III prostate cancer and currently using androgen deprivation therapy (ADT).
* All participants must meet the following criteria:

  * Taking AI or ADT for at least 3 months prior to start of study participation.
  * 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 24-hour glucose incremental area under the curve (iAUC)
timeFrame: Baseline, 24 hours of each intervention day
Secondary outcomes:
measure: 24-hour mean glucose
timeFrame: Baseline, 24 hours of each intervention day
measure: Postprandial iAUC
timeFrame: Baseline, 24 hours of each intervention day
measure: Peak postprandial glucose
timeFrame: Baseline, 24 hours of each intervention day
measure: Daytime glucose concentration
timeFrame: Baseline, 24 hours of each intervention day
measure: Nocturnal glucose concentration
timeFrame: Baseline, 24 hours of each intervention day
measure: Time in hypoglycemia
timeFrame: Baseline, 24 hours of each intervention day
measure: Time in hyperglycemia
timeFrame: Baseline, 24 hours of each intervention day
measure: Indices of glycemic variability
timeFrame: Baseline, 24 hours of each intervention day
measure: Participant acceptability
timeFrame: 24 hours of each intervention day
measure: Participant enjoyment
timeFrame: 24 hours of each intervention day
Other outcomes:
measure: Physical activity
timeFrame: 24 hours of each intervention day
measure: Systolic and Diastolic Blood Pressure
timeFrame: Baseline
measure: Waist circumference
timeFrame: Baseline
measure: Body mass index (BMI)
timeFrame: Baseline
measure: Fasting glucose
timeFrame: Baseline
measure: Fasting insulin
timeFrame: Baseline
measure: Lipid profile: HDL, LDL, total cholesterol, triglycerides
timeFrame: Baseline
measure: Hemoglobin A1c
timeFrame: Baseline
measure: Metabolic syndrome
timeFrame: Baseline
measure: Framingham 10-year cardiovascular disease risk score
timeFrame: Baseline
measure: Dietary intake
timeFrame: Baseline
measure: Perceived stress
timeFrame: Prior to start of each intervention
measure: Muscle soreness
timeFrame: Prior to start of each intervention
measure: Sleep quantity and quality
timeFrame: Baseline, 24 hours of each intervention day
Locations:
city: Toronto
country: Canada
facility: Remote Ontario-wide
state: Ontario
Study officials:
References: