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Aerobic Exercise for Breast Cancer

N/A

Waitlist Available

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

Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting

If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study

Must not have

Presence of metastatic disease

Presence of any other concurrent, actively treated malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during chemotherapy 3-6 months depending on treatment recommendations

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether aerobic exercise training during and after chemotherapy helps women with early-stage breast cancer. The participant will keep track of their own exercise sessions and report back to the staff.

Who is the study for?

This trial is for women aged 21-80 with early-stage operable breast cancer scheduled for chemotherapy, not doing more than 150 minutes of moderate to strenuous exercise weekly. They must pass a baseline exercise test without high-risk heart issues and can't be pregnant or planning pregnancy during the study. Those with other active cancers, metastatic disease, certain heart/lung conditions, mental impairments, or treated malignancies within 3 years (except skin cancer) are excluded.

What is being tested?

The study examines the impact of supervised aerobic exercise training on women undergoing chemotherapy for early-stage breast cancer. Participants will either perform exercises during or after their chemo treatment and report back to staff about their sessions.

What are the potential side effects?

While specific side effects aren't listed for this type of non-drug intervention, participants may experience typical exercise-related discomforts such as muscle soreness or fatigue. Any unusual symptoms should be reported to the ExOnc staff.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for chemotherapy before or after surgery.

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I am not pregnant nor planning to become pregnant during the study.

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I am between 21 and 80 years old.

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I am fully active or can carry out light work.

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My breast cancer is in an early stage and can be surgically removed.

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I passed a fitness test for my heart and lungs.

Exclusion Criteria

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

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My cancer has spread to other parts of my body.

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I am currently being treated for another type of cancer.

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I have not been treated for any cancer other than non-melanoma skin cancer in the last 3 years.

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I cannot undergo certain heart and lung fitness tests due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during chemotherapy 3-6 months depending on treatment recommendations

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during chemotherapy 3-6 months depending on treatment recommendations

This trial's timeline: 3 weeks for screening, Varies for treatment, and during chemotherapy 3-6 months depending on treatment recommendations for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in VO2 peak (functional capacity)

Secondary study objectives

Depression scale during and after Chemotherapy

Pharmacotherapy

Quality of Life measured by questionnaire during and after Chemotherapy

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: General Physical Activity GroupExperimental Treatment2 Interventions

Patients will receive a home-based, general physical activity program. Specifically, all patients assigned to general physical activity will receive an initial, consultation with a staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of their normal daily activity. Patients can be provided with a fitness tracker (e.g. FitBit) to evaluate exercise duration and intensity. Patients may also be provided with an exercise log to record type, duration, and average heart rate during sessions. The exercise log is provided as a guidance tool and may be, although is not required to be, returned to study staff. Staff exercise physiologists will contact patients to check progress, and answer questions.

Group II: Continuous Aerobic TrainingExperimental Treatment1 Intervention

The ultimate goal is for participants to complete 3 exercise sessions week of non-linear aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), during and after chemotherapy. For patients receiving adjuvant therapy (except those who have additional surgery after chemotherapy), VO2peak will be determined by the CPETs performed at baseline and midpoint. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, VO2peak will be determined by the CPETs or at baseline, pre- surgery, and post-surgery. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.

Group III: Aerobic Training During ChemotherapyExperimental Treatment1 Intervention

The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training an intensity of at 55% to 100% of the individually determined exercise capacity VO2peak), concurrent with chemotherapy. VO2peak will be determined by the CPET performed at baseline. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.

Group IV: Aerobic Training After ChemotherapyExperimental Treatment1 Intervention

The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training at an intensity 55% to 100% of the individually determined exercise capacity (VO2peak), after the completion of chemotherapy. VO2peak will be determined by the CPET performed at midpoint, or pre-surgery for neoadjuvant patients. For patients receiving adjuvant therapy, (except those who have additional surgery after chemotherapy), the aerobic training intervention must begin within 2 weeks of the patient's midpoint CPET. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, the aerobic training intervention will begin within approximately 6 weeks of surgery, per the discretion of the treating physician. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic Training

2024

N/A

~880

0 / 10Eligibility criteria met