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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in VO2 peak (functional capacity)

Secondary outcome measures

Depression scale during and after Chemotherapy

Pharmacotherapy

Quality of Life measured by questionnaire during and after Chemotherapy

+2 more

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

2020

N/A

~830

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,476 Total Patients Enrolled

202 Trials studying Breast Cancer

80,993 Patients Enrolled for Breast Cancer

Jessica Scott, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

6 Previous Clinical Trials

696 Total Patients Enrolled

2 Trials studying Breast Cancer

314 Patients Enrolled for Breast Cancer

Media Library

Aerobic Training Clinical Trial Eligibility Overview. Trial Name: NCT01943695 — N/A

Breast Cancer Research Study Groups: Aerobic Training After Chemotherapy, Continuous Aerobic Training, General Physical Activity Group, Aerobic Training During Chemotherapy

Breast Cancer Clinical Trial 2023: Aerobic Training Highlights & Side Effects. Trial Name: NCT01943695 — N/A

Aerobic Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT01943695 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age cap for those eligible to join this trial?

"The age range for the participants of this clinical trial is between 21 and 80 years old."

Answered by AI

Are there any eligibility requirements that would permit my participation in this experiment?

"Eligibility criteria for this medical trial include a diagnosis of breast cancer and an age range between 21 to 80 years old. The total number of patients being recruited is 144."

Answered by AI

Is this research initiative currently open to patient enrollment?

"The data on clinicaltrials.gov reveals that this medical study, which was initiated in 2013 and last updated in 2022, is currently not enrolling patients. However, there are 2,602 other trials actively recruiting at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

2013. "Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01943695.