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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether exercise can help breast cancer patients feel better during chemotherapy. Researchers aim to determine if working out can improve heart health, reduce inflammation, and enhance overall quality of life. Participants will engage in either high-intensity biking (High Intensity Interval Exercise) or moderate-intensity walking to identify the most effective approach. The trial seeks individuals with breast cancer who are beginning chemotherapy and have received medical clearance to exercise. As an unphased trial, it provides a unique opportunity to explore the potential benefits of exercise during chemotherapy.

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 prior data suggests that these exercise protocols are safe for breast cancer patients undergoing chemotherapy?

Research has shown that high-intensity interval exercise (HIIT) is generally safe for breast cancer patients. Studies have found that HIIT strengthens muscles, reduces fatigue, and improves quality of life without major safety concerns. Participants often experience better cardiovascular fitness and fewer emotional issues. There are no significant reports of negative effects from HIIT in breast cancer patients.

Research has also found moderate-intensity walking to be well-tolerated and beneficial. Walking during chemotherapy can help reduce cancer-related fatigue. Studies show that moderate activity can improve survival rates and overall quality of life for women with advanced breast cancer.

Both types of exercise appear to be safe options, offering benefits for fitness and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise-based treatments because they offer a unique, non-pharmaceutical approach to supporting breast cancer patients undergoing chemotherapy. Unlike traditional treatments like medication and surgery, these exercise regimens—high intensity interval exercise and moderate intensity walking—focus on enhancing physical fitness and potentially improving overall well-being. High intensity interval exercise is distinctive for its delivery, with participants using a recumbent bike at home and targeting 85-90% of their heart rate max, which can help maintain cardiovascular health. Meanwhile, the moderate intensity walking program encourages consistent activity with the goal of reaching 150 minutes per week, using tools like heart rate monitors and activity trackers to engage participants. Both approaches emphasize patient empowerment and active participation, adding a holistic dimension to cancer care.

What evidence suggests that this trial's treatments could be effective for breast cancer patients undergoing chemotherapy?

In this trial, participants will follow one of two exercise regimens. High-intensity interval training (HIIT), which some participants may receive, has greatly improved fitness, muscle strength, and quality of life in breast cancer patients, as shown in previous studies. It also helps reduce fatigue and manage emotional symptoms during treatment. One study found that HIIT can maintain heart and lung fitness, which often decreases during chemotherapy. Meanwhile, moderate-intensity walking, another exercise method tested in this trial, has significantly reduced fatigue in breast cancer patients undergoing chemotherapy. Walking at a moderate pace can also boost physical activity levels, which is beneficial during cancer treatment. Both exercise methods have shown promising effects in supporting breast cancer patients through their treatments. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524023/

High‐intensity interval training in breast cancer patients HIIT is a time‐efficient alternative to MICT for improving VO 2peak and may also enhance muscle strength and alleviate fatigue and emotional symptoms in breast ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1440244023004218

Clinical updates on the effects of high intensity interval ... This review and meta-analysis demonstrated that HIIT exercise significantly improved aerobic fitness, fatigue, quality of life, pain and diastolic blood ...

3. nature.com nature.com/articles/s41598-025-18377-0

A randomized trial on the feasibility of high-intensity ... The OptiTrain trial showed that HIIT combined with resistance training can significantly improve muscle strength in breast cancer patients ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04724499

Improving Cognitive Function Through High-intensity ... This study intends to evaluate whether HIIT can improve cognitive function as well as cardio-respiratory fitness, among patients undergoing chemotherapy for ...

5. link.springer.com link.springer.com/article/10.1007/s00421-025-05822-1

Supervised high-intensity interval training reduces the ... Supervised HIIT implemented alongside chemotherapy can mitigate the decline in cardiorespiratory fitness caused by BC chemotherapy in young patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7897878/

High-intensity interval training in breast cancer survivors This review found that all studies on HIIT for breast cancer survivors investigated lab-based, supervised interventions, but not home-based or unsupervised.