What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as surgery, chemotherapy, radiation therapy, and hormone therapy, can have various side effects. Surgery may lead to pain, swelling, and lymphedema. Chemotherapy often causes fatigue, nausea, hair loss, and increased infection risk. Radiation therapy can result in skin irritation, fatigue, and swelling. Hormone therapy may cause hot flashes, mood swings, and bone thinning. Exercise interventions, like those studied in the Adaptive Aerobic Training trial, generally improve cardiorespiratory fitness and reduce fatigue, but they may also cause muscle soreness and require careful monitoring to avoid overexertion.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including chemotherapy, hormone therapy, targeted therapy, and immunotherapy. While specific FDA approvals for exercise-based treatments like adaptive aerobic training are not detailed, exercise is widely recognized as a beneficial adjunct therapy for improving quality of life and cardiorespiratory fitness in breast cancer patients. The American Society of Clinical Oncology (ASCO) recommends aerobic and resistance exercise during active cancer treatment to enhance fitness, strength, and reduce fatigue.

What other types of research exist?

Promising alternatives to Adaptive Aerobic Training for breast cancer patients include: 1) Resistance/Strength Training, which has shown improvements in maximal strength and quality of life measures; 2) Tai Chi, which has demonstrated similar or greater symptomatic improvement compared to aerobic exercise; and 3) Yoga, which has been beneficial for physical function and quality of life. These alternatives can be tailored to individual patient needs and preferences.

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Aerobic Exercise for Breast Cancer

Phase 2

Recruiting

Led By Jessica Scott, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Female

Aged ≥18 years

Must not have

Contraindications to cardiopulmonary exercise testing including acute myocardial infarction within 3-5 days of any planned study procedures, unstable angina, uncontrolled arrhythmia causing symptoms or hemodynamic compromise, recurrent syncope, active endocarditis, acute myocarditis or pericarditis, symptomatic severe aortic stenosis, uncontrolled heart failure, acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures, thrombosis of lower extremities, suspected dissecting aneurysm, uncontrolled asthma, pulmonary edema, respiratory failure, acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis), room air desaturation at rest ≤ 85%

Mental impairment leading to inability to cooperate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 32 weeks from baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two types of walking exercises: one with a fixed routine and one that changes based on how participants respond. The goal is to see which method better improves heart and lung fitness. Participants are people who can benefit from regular walking exercises.

Who is the study for?

This trial is for women over 18 with primary breast cancer, scheduled to receive chemotherapy, and currently exercising less than 90 minutes per week. They must be able to perform a baseline exercise test and agree to follow study procedures. It's not for those with other invasive cancers, severe heart or lung conditions, mental impairments affecting cooperation, or any illness that could interfere with the study.

What is being tested?

The study compares two types of Aerobic Training (AT) in breast cancer patients undergoing chemotherapy: Standard AT involves a fixed amount of walking each week; Adaptive AT adjusts exercise levels based on participants' responses. The effect on participants' cardiorespiratory fitness (CRF) will be evaluated.

What are the potential side effects?

While the trial focuses on aerobic training rather than medication side effects, potential risks may include typical exercise-related issues such as muscle soreness, fatigue, joint pain or injury. Participants' health will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

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I am female.

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I am 18 years old or older.

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I have been diagnosed with breast cancer and am scheduled for or receiving chemotherapy.

Exclusion Criteria

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

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I don't have recent severe heart or lung issues that would stop me from safely doing exercise tests.

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I am able to understand and follow study procedures.

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 32 weeks from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~32 weeks from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks from 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

Cardiorespiratory fitness (CRF) response rate

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: Adaptive Aerobic Training/AT DosingExperimental Treatment1 Intervention

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Group II: Standard (fixed) Aerobic Training/AT dosingActive Control1 Intervention

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

0 / 6Eligibility 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, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Surgery and radiation aim to remove or destroy cancer cells in the breast. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells, throughout the body. Hormone therapy blocks hormones like estrogen that can promote cancer growth, while targeted therapy focuses on specific molecules involved in cancer cell growth and survival. Adaptive aerobic training, which adjusts exercise levels based on participants' responses, is important for breast cancer patients as it can improve cardiorespiratory fitness, reduce fatigue, and enhance overall quality of life during and after treatment.