Aerobic Exercise for Breast Cancer Survivors

(ROME Trial)

Overseen By Ildiko Nyikos, M.A., ACSM-RCEP

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Steroids, Antibiotics

Disqualifiers: Metastatic cancer, Unstable angina, Schizophrenia, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aerobic exercise affects the gut health of women who have survived breast cancer. Researchers aim to determine if changes in gut health can reduce symptoms like fatigue. Participants will either engage in supervised aerobic exercise sessions (known as Aerobic Exercise Training) or participate in non-aerobic activities for comparison. Women who completed their primary breast cancer treatment at least a year ago and experience frequent fatigue might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how lifestyle changes can improve post-cancer health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you do not change your usual medications during the study period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that aerobic exercise is generally safe for breast cancer survivors. It can help reduce treatment-related side effects and improve quality of life. One study found that moderate-to-high intensity aerobic exercise, when supervised, is safe and can lead to better health outcomes.

Overall, exercise is recommended for cancer survivors. It is a safe activity that offers many health benefits, making it a good option for those looking to improve fitness and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about aerobic exercise training for breast cancer survivors because it offers a unique, non-invasive way to potentially improve health outcomes beyond traditional treatments like surgery, chemotherapy, and hormonal therapy. Unlike these standard options, which primarily target cancer cells, aerobic exercise focuses on enhancing overall physical fitness, reducing fatigue, and improving quality of life. The supervised, progressive nature of these exercise sessions, facilitated by specialists experienced in working with cancer survivors, ensures that participants receive personalized, safe, and effective training. By exploring this approach, researchers hope to uncover additional benefits that go hand-in-hand with existing cancer treatments.

What evidence suggests that aerobic exercise training could be effective for breast cancer survivors?

Research has shown that aerobic exercise, which participants in this trial may receive, can greatly benefit breast cancer survivors. Studies have found that it boosts energy levels and improves physical abilities, enhancing quality of life. Exercise also reduces cancer-related fatigue, a common issue after treatment. Additionally, aerobic exercise helps maintain a healthy weight and improves heart and lung health. Overall, regular aerobic activity plays a crucial role in recovery and well-being. ^{1 3 6 7 8}

Who Is on the Research Team?

Laura Q Rogers, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for women aged 18-74 who are breast cancer survivors (stage 0, I, II, or III) and have been free from primary treatment for at least a year. Participants should not be taking probiotics or antibiotics recently, must be able to walk without help, have low exercise capacity, experience fatigue, and get medical clearance.

Inclusion Criteria

Physician medical clearance for study participation

English speaking

I haven't taken any antibiotics in the last 90 days.

Exclusion Criteria

I have unstable chest pain.

I am planning to have surgery during the study.

You have dementia or a brain disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Training

Participants undergo 10 weeks of progressive aerobic exercise training supervised by exercise specialists

10 weeks

Regular supervised sessions

Follow-up

Participants are monitored for changes in gut microbiota, fatigue, and other physiological and psychosocial measures

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise Training
• Attention Control

Trial Overview

The study aims to explore how aerobic exercise affects the gut microbiome in breast cancer survivors and its potential link to reducing fatigue. Participants will either engage in an aerobic exercise program or be part of an attention control group that does not receive this intervention.

How Is the Trial Designed?

Group I: Aerobic Exercise Training Experimental Treatment 1 Intervention

Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.

Group II: Attention Control Active Control 1 Intervention

The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 20 breast cancer patients undergoing neoadjuvant chemotherapy, those who participated in moderate-to-high intensity aerobic training showed a significant improvement in cardiopulmonary function, with a 13.3% increase in VO2peak compared to a decrease in the control group.

The aerobic training was found to be safe, with only one adverse event reported during the training sessions, and no significant differences in treatment-related side effects between the groups, indicating that it can be a beneficial adjunct therapy during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. Hornsby, WE., Douglas, PS., West, MJ., et al.[2022]

Engaging in moderate to vigorous physical activity for 3-5 days a week can reduce the risk of breast cancer by 20-40% and significantly lower the risk of death from breast cancer by 50-53% in survivors.

Breast cancer survivors are encouraged to participate in rehabilitation programs that include both strength and aerobic exercises, as these can improve physical functioning, reduce fatigue, enhance immune function, and boost overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in the prevention and rehabilitation of breast cancer. Volaklis, KA., Halle, M., Tokmakidis, SP.[2021]

A six-week mild- to moderate-intensity aerobic exercise program significantly reduced fatigue in Taiwanese women with breast cancer undergoing radiotherapy, while fatigue increased in the control group without exercise.

The study involved 58 women, with results indicating that aerobic exercise can be an effective intervention to improve quality of life by alleviating cancer-related fatigue during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an aerobic exercise programme on fatigue for patients with breast cancer undergoing radiotherapy. Yang, TY., Chen, ML., Li, CC.[2018]

Aerobic exercise therapy significantly improved quality of life (QoL) in women treated for breast cancer, with a notable mean difference of 9.8 units in the primary outcome measure compared to usual care after 8 weeks.

The benefits of aerobic exercise therapy extended to various aspects of well-being, including social/family and functional well-being, and were not observed in the exercise-placebo group, indicating that the improvements were specifically due to the aerobic exercise intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of exercise therapy in women treated for breast cancer. Daley, AJ., Crank, H., Saxton, JM., et al.[2022]

A systematic review of 12 randomized controlled trials found that aerobic exercise significantly improves the quality of life for breast cancer survivors, helping to alleviate symptoms of depression and anxiety.

Despite the mental health benefits, aerobic exercise did not show significant effects on weight loss in breast cancer survivors, indicating its primary benefits may be in emotional and quality of life improvements rather than physical weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Aerobic Exercise for Breast Cancer Survivors: A Systematic Review of Randomized Controlled Trials. Bekhet, AH., Abdallah, AR., Ismail, HM., et al.[2020]

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]

The HEALTh program, a customized cardiac rehabilitation model for female breast cancer survivors, significantly improved cardiorespiratory fitness by 14% and enhanced quality of life and reduced depressive symptoms after 22 sessions.

With a program adherence rate of 66.6%, the study involved 152 breast cancer survivors, demonstrating that structured exercise and education can effectively support physical and mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. Dolan, LB., Barry, D., Petrella, T., et al.[2019]

Aerobic exercise is an effective additive treatment for cancer patients, helping to alleviate physical limitations and improve quality of life during and after oncological treatment.

Research indicates that aerobic exercise is feasible even for patients with advanced cancer, enabling them to recover physical function and return to a more active lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aerobic endurance training for cancer patients]. Crevenna, R., Zielinski, C., Keilani, MY., et al.[2019]

A 3-week moderate intensity aerobic training program significantly improved aerobic capacity (VO2max) in 18 female breast cancer survivors, with increases of 11.86% in one group and 17.72% in another group.

The study demonstrated that both a predefined workload based on VO2max and a subjective exertion level led to similar improvements in aerobic capacity, indicating flexibility in training approaches for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a short-term differently dosed aerobic exercise on maximum aerobic capacity in breast cancer survivors: a pilot study. Brdareski, Z., Djurović, A., Susnjar, S., et al.[2022]

A supervised exercise program for breast cancer survivors showed significant improvements in motivational factors related to exercise, particularly in autonomy, with a notable increase in the immediate exercise group compared to the delayed group.

The study involved 60 participants and achieved a 61.3% adherence rate, suggesting that early engagement in exercise can foster a positive attitude towards physical activity, potentially leading to better long-term adherence post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a combined resistance and aerobic exercise program on motivational variables in breast cancer survivors: a randomized controlled trial. Milne, HM., Wallman, KE., Gordon, S., et al.[2018]

A systematic review of nine randomized controlled trials found that aerobic exercise, often combined with resistance training, significantly improves the quality of life for breast cancer patients and survivors.

The most effective exercise programs typically involved three sessions per week at a moderate intensity (50% to 80% of maximum heart rate) for over 30 minutes, all supervised by a physiotherapist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise parameters in the management of breast cancer: a systematic review of randomized controlled trials. Pastakia, K., Kumar, S.[2022]

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