Alternative Physical Activity Strategies for Breast and Prostate Cancer Survivors

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Prostate Cancer; Insulin Resistance; Cardiometabolic Risk Factors

• Registration Number: NCT06633380
• Lead Sponsor: University of Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-13
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Study Start: 2024-10-15
• Primary Completion: 2025-01-30
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
24-hour glucose incremental area under the curve (iAUC)	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.

Secondary Outcome Measures

Name	Time	Method
24-hour mean glucose	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.
Postprandial iAUC	Baseline, 24 hours of each intervention day	Assessed for each single-day intervention using a continuous glucose monitor for two hours following each meal.
Peak postprandial glucose	Baseline, 24 hours of each intervention day	Assessed as the highest glucose concentration during the 2 hours following each meal using a continuous glucose monitor.
Daytime glucose concentration	Baseline, 24 hours of each intervention day	Assessed for each single-day intervention using a continuous glucose monitor from 6:00 am to 12:00 am on the intervention day.
Nocturnal glucose concentration	Baseline, 24 hours of each intervention day	Assessed for each single-day intervention using a continuous glucose monitor from 12:00 am to 6:00 am on the intervention day.
Time in hypoglycemia	Baseline, 24 hours of each intervention day	Assessed as the number of hours with glucose less than 3.9 mmol/L using a continuous glucose monitor.
Time in hyperglycemia	Baseline, 24 hours of each intervention day	Assessed as the number of hours with glucose greater than 10 mmol/L using a continuous glucose monitor.
Indices of glycemic variability	Baseline, 24 hours of each intervention day	Indices include standard deviation, coefficient of variation, mean amplitude of glycemic excursion, and continuous overall net glycemic action
Participant acceptability	24 hours of each intervention day	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.
Participant enjoyment	24 hours of each intervention day	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.

Trial Locations

Locations (1)

Remote Ontario-wide; 🇨🇦 Toronto, Ontario, Canada