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Behavioural Intervention
High-Intensity Interval Training (HIIT) After Breast Cancer Chemotherapy
N/A
Recruiting
Led By Demetra Christou, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 to 85 years
Female patients based on biological sex
Must not have
Lymphedema stage ≥2 prior to study enrollment
Any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, following a 12-week intervention period, following a 12-week observation period
Awards & highlights
No Placebo-Only Group
Summary
This trial will examine if a new type of exercise can help reduce CVD risk in breast cancer survivors, who are more likely to get CVD due to chemotherapy.
Who is the study for?
This trial is for female breast cancer survivors, aged 18-85, who finished chemotherapy over 6 months ago but less than a year. They should not have severe lymphedema or cardiovascular diseases and mustn't be pregnant or involved in other studies that could affect results.
What is being tested?
The study tests high-intensity interval training against moderate-intensity continuous training for improving heart health after breast cancer treatment. It includes a 12-week exercise program followed by a 12-week observation period to see which method is more effective.
What are the potential side effects?
While the document doesn't list specific side effects, exercise programs can sometimes lead to muscle soreness, fatigue, and in rare cases with intense activity, there's a risk of injury or exacerbating underlying health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
Select...
I am biologically female.
Select...
I have been diagnosed with early-stage (I-III) breast cancer that has not spread.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have moderate to severe lymphedema.
Select...
I have a history of significant heart problems.
Select...
I finished my cancer treatment, except for ovarian suppression, within the last 6 months.
Select...
I am scheduled for cancer treatment other than ovarian suppression during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, following a 12-week intervention period, following a 12-week observation period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, following a 12-week intervention period, following a 12-week observation period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in brachial FMD
Change in cardiac function (global longitudinal strain)
Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Usual Care (UC)Experimental Treatment2 Interventions
Research participants will continue their habitual physical activity for the duration of the study. Once they complete the study, they will have the opportunity to perform supervised HIIT or MICT at home for 3 days/week for 12 weeks (research participants can choose either type of exercise).
Group II: Moderate Intensity Continuous Training (MICT)Experimental Treatment2 Interventions
Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
Group III: High Intensity Interval Training (HIIT)Experimental Treatment2 Interventions
Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,393 Previous Clinical Trials
766,866 Total Patients Enrolled
15 Trials studying Breast Cancer
1,085 Patients Enrolled for Breast Cancer
National Institute on Aging (NIA)NIH
1,782 Previous Clinical Trials
28,183,935 Total Patients Enrolled
11 Trials studying Breast Cancer
39,812 Patients Enrolled for Breast Cancer
Demetra Christou, PhDPrincipal InvestigatorUniversity of Florida
7 Previous Clinical Trials
279 Total Patients Enrolled
1 Trials studying Breast Cancer
68 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been regularly doing moderate-intensity aerobic exercise for at least 150 minutes each week for the past 6 months.I am between 18 and 85 years old.I finished my breast cancer chemotherapy 6-12 months ago.I am biologically female.I have moderate to severe lymphedema.I have a history of significant heart problems.I finished my cancer treatment, except for ovarian suppression, within the last 6 months.I am scheduled for cancer treatment other than ovarian suppression during the study.I have been diagnosed with early-stage (I-III) breast cancer that has not spread.
Research Study Groups:
This trial has the following groups:- Group 1: Moderate Intensity Continuous Training (MICT)
- Group 2: Usual Care (UC)
- Group 3: High Intensity Interval Training (HIIT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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