What side effects are associated with this type of intervention?

Common treatments for breast cancer, including chemotherapy, radiation therapy, and hormone therapy, have several known side effects. Chemotherapy often causes fatigue, nausea, vomiting, hair loss, and increased infection risk. Radiation therapy can lead to skin irritation, fatigue, and changes in breast tissue. Hormone therapy may result in hot flashes, vaginal dryness, and an increased risk of blood clots. Additionally, these treatments can affect bone health and contribute to psychological symptoms like depression and anxiety.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including targeted therapies like pembrolizumab for high-risk early-stage triple-negative breast cancer, which showed significant improvement in pathologic complete response rate and event-free survival. While specific approvals related to exercise-induced changes in the gut microbiome are not detailed, the role of physical activity in improving quality of life and reducing fatigue among cancer survivors is well-documented. These findings suggest that integrating exercise into treatment plans could potentially enhance overall outcomes for breast cancer patients.

What other types of research exist?

Promising novel alternatives to exercise for breast cancer patients considering treatment in 2024 include dietary interventions aimed at modulating the gut microbiome, such as prebiotics, probiotics, and synbiotics. These interventions can potentially improve gut health and alleviate psychosocial symptoms like fatigue and depression. Additionally, mind-body practices such as yoga and mindfulness meditation may also offer benefits by reducing stress and improving overall quality of life.

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Aerobic Exercise for Breast Cancer Survivors (ROME Trial)

N/A

Recruiting

Led By Laura Q Rogers, MD, MPH

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation)

No antibiotics for the past 90 days

Must not have

Unstable angina

Anticipate elective surgery during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks after baseline

Awards & highlights

No Placebo-Only Group

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for this type of non-drug intervention, participants may experience general discomforts associated with new exercise routines such as muscle soreness or increased fatigue initially.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I can walk on my own without help.

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I have felt quite tired, rating my fatigue 3 or higher out of 10, over the last week.

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I am a woman aged 18-74 with a history of early to mid-stage breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have unstable chest pain.

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I am planning to have surgery during the study.

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I expect to need antibiotics during the study.

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I have not been diagnosed with any cancer other than skin or cervical cancer in situ in the past 5 years.

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I have heart failure that affects my daily activities.

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I live or work more than 50 miles away from the study site or I can't get there.

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My BMI is over 50.

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I am currently taking steroids.

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My cancer has spread or come back.

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My asthma is not well-managed.

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I have interstitial lung disease.

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I have a diagnosed connective tissue or rheumatologic disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composition of gut microbiota as measured by fecal samples

Secondary study objectives

Electrocardiogram

Concentration of cortisol measured through hair sample

Fatigue

+2 more

Other study objectives

Accelerometer Measured Free-living physical activity (e.g., minutes of activity)

Absorptiometry, X-Ray

FACT-B self-administered survey measuring quality of life

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Aerobic Exercise TrainingExperimental Treatment1 Intervention

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

Group II: Attention ControlActive Control1 Intervention

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

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include surgery, which physically removes the tumor; radiation therapy, which uses high-energy rays to kill cancer cells; chemotherapy, which uses drugs to destroy rapidly dividing cells; hormone therapy, which blocks hormones like estrogen that fuel certain cancers; and targeted therapy, which attacks specific molecules involved in cancer growth. Understanding these mechanisms is crucial for breast cancer patients as it informs the potential side effects and long-term impacts of treatment. For instance, exercise has been shown to positively affect the gut microbiome and reduce psychosocial symptoms such as fatigue, which can be particularly beneficial for patients dealing with the side effects of these treatments.