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

126 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how exercise and a specific diet can change gut bacteria in breast cancer survivors to help reduce tiredness and improve 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.

What data supports the effectiveness of the treatment Aerobic Exercise Training for breast cancer survivors?

Research shows that aerobic exercise can significantly benefit breast cancer survivors by improving their quality of life, reducing fatigue, and helping them regain physical function. It also supports emotional well-being and may reduce the risk of cancer relapse. ^{1 2 3 4 5}

Is aerobic exercise safe for breast cancer survivors?

Aerobic exercise is generally safe for breast cancer survivors and can provide significant benefits, such as reducing fatigue and improving quality of life. However, exercise programs may need to be adjusted for individuals experiencing specific conditions like fatigue, nausea, or lymphedema (swelling due to lymph fluid). ^{1 6 7 8 9}

How does aerobic exercise training differ from other treatments for breast cancer survivors?

Aerobic exercise training is unique because it focuses on improving physical fitness and quality of life through regular, moderate-intensity exercise sessions, which can help reduce fatigue, improve mood, and enhance overall well-being. Unlike traditional medical treatments, it emphasizes a holistic approach by incorporating enjoyable activities, social interaction, and skill development, tailored to the individual's needs and limitations. ^{1 5 7 10 11}

Research Team

Laura Q Rogers, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

It's been over a year since I finished my initial breast cancer treatment.

Exclusion Criteria

I have unstable chest pain.

I am planning to have surgery during the study.

You have dementia or a brain disorder.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

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

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

2. Serbia 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. [2022]

3. England 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. [2018]

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

Exercise parameters in the management of breast cancer: a systematic review of randomized controlled trials. [2022]

5. Austria pubmed.ncbi.nlm.nih.gov

[Aerobic endurance training for cancer patients]. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. [2022]

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

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. [2019]

8. Austria pubmed.ncbi.nlm.nih.gov

Exercise in the prevention and rehabilitation of breast cancer. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Effects of an aerobic exercise programme on fatigue for patients with breast cancer undergoing radiotherapy. [2018]

10. Thailand pubmed.ncbi.nlm.nih.gov

Benefits of Aerobic Exercise for Breast Cancer Survivors: A Systematic Review of Randomized Controlled Trials. [2020]

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

Randomized trial of exercise therapy in women treated for breast cancer. [2022]