Exercise for Breast Cancer Patients Undergoing Chemotherapy

Overseen By Zach Leicht, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Cardiac disease, Uncontrolled hypertension, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if exercise preconditioning can mitigate the off target effects of chemotherapy treatment on measures of cardiovascular function, inflammatory responses, and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that medication non-compliance is an exclusion criterion, which might suggest that staying on your prescribed medications is important.

What data supports the effectiveness of the treatment for breast cancer patients undergoing chemotherapy?

Research shows that high-intensity interval training (HIIT) can improve cardiovascular fitness and reduce cancer-related fatigue in breast cancer patients undergoing chemotherapy. It also enhances health-related quality of life and physical function, making it a beneficial addition to conventional exercise programs during treatment. ^{1 2 3 4 5}

Is high-intensity interval training (HIIT) safe for breast cancer patients undergoing chemotherapy?

Research suggests that high-intensity interval training (HIIT) is generally safe for breast cancer patients undergoing chemotherapy, as it has been shown to improve physical function and reduce fatigue without significant adverse effects. ^{1 2 3 6 7}

How is the exercise treatment for breast cancer patients undergoing chemotherapy different from other treatments?

This treatment involves high-intensity interval exercise (HIIT), which is unique because it can significantly improve cardiorespiratory fitness and reduce fatigue more effectively than moderate continuous exercise, especially during chemotherapy. Unlike traditional treatments, it combines short bursts of intense activity with rest periods, making it a novel approach for enhancing physical function in breast cancer patients. ^{1 6 7 8 9}

Eligibility Criteria

This trial is for adults over 18 with breast cancer (Stage I-III or minimal burden IV) who are about to start certain chemotherapies and can exercise. They must be cleared by a doctor, speak English, and not have had cardiotoxic chemo before. People with recent severe heart issues, uncontrolled high blood pressure, major organ diseases, pregnancy, or conditions that make exercising unsafe cannot join.

Inclusion Criteria

I have breast cancer (early or minimal stage IV) and am on specific chemotherapy.

Physician clearance for exercise training

Ability to speak/understand English

Exclusion Criteria

I have not had a heart attack or unstable angina in the last 4 weeks.

Pregnant women

I have been diagnosed with acute myocarditis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconditioning

Remotely-monitored exercise training starts one week prior to chemotherapy

1 week

Remote monitoring

Treatment

Participants undergo adjuvant or neoadjuvant chemotherapy with concurrent remotely-monitored exercise interventions

16 weeks

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• High Intensity Interval Exercise
• Moderate Intensity Walking

Trial Overview The study tests if two types of exercise—moderate intensity walking and high-intensity interval training—can reduce the negative effects of chemotherapy on heart health, inflammation levels, and life quality in breast cancer patients.

Participant Groups

Group I: Moderate Intensity Walking Experimental Treatment 1 Intervention

Subjects allocated to moderate intensity walking will be given a gift card to purchase a paid of running shoes. A chest-based heart rate monitor and an activity tracker watch will be provided. Subjects will aim to achieve 150 minutes a week of moderate intensity walking. Subjects will also be receiving text messages, phone calls, and emails from study staff to gauge and encourage subject participation and physical activity.

Group II: High Intensity Interval Exercise Experimental Treatment 1 Intervention

Subjects will receive a recumbent bike to be delivered and assembled to their home as well as a heart rate monitor and activity tracker. Subjects will undergo high intensity interval exercise 3 days a week, with the goal of achieving 85-90% of their heart rate max. Subjects will also be receiving text messages, phone calls, and emails from study staff to gauge and encourage subject participation and physical activity.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Findings from Research

High-intensity interval training (HIIT) has been shown to significantly improve cardiorespiratory fitness in breast cancer survivors, based on a review of 13 randomized controlled trials.

All HIIT interventions were supervised and lab-based, indicating a need for further research into the feasibility and effectiveness of home-based or unsupervised HIIT programs for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training in breast cancer survivors: a systematic review. Tsuji, K., Matsuoka, YJ., Ochi, E.[2021]

High-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) both improved aerobic capacity (VO2peak) and waist circumference in breast cancer survivors over a 12-week program, but there were no significant differences between the two training methods.

While HIIT led to increases in minute ventilation and peak workload, it did not result in a greater improvement in VO2peak compared to MICT, suggesting that both training intensities are beneficial for previously trained breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional cardiovascular fitness when progressing from moderate- to high-intensity exercise training in previously trained breast cancer survivors. Bell, RA., Baldi, JC., Jones, LM.[2021]

An 8-week high-intensity interval training (HIIT) program significantly improved physical function in breast cancer patients undergoing chemotherapy, as evidenced by better performance in the Margaria-Kalamen stair climb test and the 6-minute walk test.

Despite the physical improvements, the HIIT intervention did not lead to significant changes in patient-reported outcomes related to quality of life or fatigue, suggesting that while HIIT can enhance physical capabilities, it may not directly impact perceived well-being during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of high-intensity interval training on patient-reported outcomes and physical function in women with breast cancer receiving anthracycline-based chemotherapy. Lee, K., Norris, MK., Wang, E., et al.[2021]

In a study involving 240 women undergoing chemotherapy for breast cancer, resistance and high-intensity interval training (RT-HIIT) significantly reduced cancer-related fatigue (CRF) compared to usual care, improving daily life and physical symptoms.

Both RT-HIIT and moderate-intensity aerobic training (AT-HIIT) enhanced health-related quality of life, with RT-HIIT also reducing overall symptom burden, highlighting the importance of structured exercise in cancer rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding high-intensity interval training to conventional training modalities: optimizing health-related outcomes during chemotherapy for breast cancer: the OptiTrain randomized controlled trial. Mijwel, S., Backman, M., Bolam, KA., et al.[2019]

A six-week exercise intervention combining high-intensity interval endurance and strength training significantly improved endurance (12% increase in VO2 peak) and strength (26% increase in cumulative load) in 15 breast cancer patients, while no adverse events were reported.

The intervention also enhanced the quality of life for participants, suggesting that this type of exercise can be safely integrated into the treatment plan for breast cancer patients, especially during medical treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effects of a combined adjuvant high-intensity interval/strength training in breast cancer patients: a single-center pilot study. Schulz, SVW., Laszlo, R., Otto, S., et al.[2018]

In a study involving 240 women undergoing chemotherapy for breast cancer, 16 weeks of concurrent resistance and high-intensity interval training (RT-HIIT) significantly improved muscle strength and reduced pain sensitivity compared to usual care.

Both RT-HIIT and moderate-intensity aerobic plus high-intensity interval training (AT-HIIT) effectively prevented declines in cardiorespiratory fitness and limited increases in body mass, demonstrating that these exercise programs are safe and beneficial during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Highly favorable physiological responses to concurrent resistance and high-intensity interval training during chemotherapy: the OptiTrain breast cancer trial. Mijwel, S., Backman, M., Bolam, KA., et al.[2019]

High-intensity interval training (HIIT) is a feasible exercise strategy for breast cancer patients undergoing anthracycline-based chemotherapy, with 80% of participants attending the majority of sessions and completing an average of 78 minutes of exercise per week.

The HIIT intervention successfully maintained cardiorespiratory fitness (VO2max) in participants, while the control group experienced a significant decline in VO2max, highlighting the potential of HIIT to counteract the negative effects of chemotherapy on fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of high intensity interval training in patients with breast Cancer undergoing anthracycline chemotherapy: a randomized pilot trial. Lee, K., Kang, I., Mack, WJ., et al.[2023]

Exercise significantly benefits breast cancer survivors, with recommendations for moderate-intensity aerobic activity 3 to 5 days a week for 20 to 60 minutes, along with resistance training.

Psychological health improves with enjoyable exercise that includes social interaction and skill development, while modifications may be needed for conditions like fatigue or lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. Courneya, KS., Mackey, JR., McKenzie, DC.[2010]

A 10-week aerobic interval-training program significantly improved the functional capacity (VO2Lmax) of 45 women undergoing chemotherapy for Stage II breast cancer, compared to those in placebo and control groups.

The exercise group not only showed enhanced VO2Lmax but also improved workload and test time, indicating that structured aerobic training can be an effective intervention for cancer patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of aerobic interval training on cancer patients' functional capacity. MacVicar, MG., Winningham, ML., Nickel, JL.[2007]

References

1. England pubmed.ncbi.nlm.nih.gov

High-intensity interval training in breast cancer survivors: a systematic review. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Additional cardiovascular fitness when progressing from moderate- to high-intensity exercise training in previously trained breast cancer survivors. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Effect of high-intensity interval training on patient-reported outcomes and physical function in women with breast cancer receiving anthracycline-based chemotherapy. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Adding high-intensity interval training to conventional training modalities: optimizing health-related outcomes during chemotherapy for breast cancer: the OptiTrain randomized controlled trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility and effects of a combined adjuvant high-intensity interval/strength training in breast cancer patients: a single-center pilot study. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Highly favorable physiological responses to concurrent resistance and high-intensity interval training during chemotherapy: the OptiTrain breast cancer trial. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility of high intensity interval training in patients with breast Cancer undergoing anthracycline chemotherapy: a randomized pilot trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. [2010]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of aerobic interval training on cancer patients' functional capacity. [2007]