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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 below

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I am between 18 and 85 years old.

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I am biologically female.

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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:

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I have moderate to severe lymphedema.

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I have a history of significant heart problems.

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I finished my cancer treatment, except for ovarian suppression, within the last 6 months.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, following a 12-week intervention period, following a 12-week observation period for reporting.

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 more

Awards & 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.

0 / 7Eligibility criteria met