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Exercise Therapy for Breast Cancer

N/A

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

Post-menopausal, defined as one of the following: Age ≥ 45 with no menses for at least 2 years, Chemically and/or surgically induced menopause through ovarian suppression, as determined by the primary oncologist, Estradiol level of ≤30 pg/mL

Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria: Achieving a plateau in oxygen consumption, concurrent with an increase in power output, A respiratory exchange ratio ≥ 1.10, Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]), Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 32 weeks

Awards & highlights

Study Summary

This trial will study the effects of different amounts of aerobic exercise on cardiorespiratory fitness.

Who is the study for?

This trial is for post-menopausal women aged 21-80 who have completed treatment for early stage (I-III) breast cancer within the last 1-5 years. Participants should be able to perform a baseline exercise test without high-risk heart issues and must have lower than expected fitness levels for their age.Check my eligibility

What is being tested?

The study tests how different amounts and durations of aerobic exercise affect cardiovascular health in participants. It measures oxygen use, heart function, lung capacity, and blood vessel health through various exercise programs.See study design

What are the potential side effects?

Aerobic exercise is generally safe but can include muscle soreness, fatigue, joint pain or discomfort during activity. Rarely, it may trigger underlying heart conditions in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am post-menopausal, as defined by age, lack of menstruation, treatment, or hormone levels.

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I can complete a fitness test without showing signs of heart risk.

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It's been 1-5 years since I completed my cancer treatment involving surgery and either radiation, chemotherapy, or trastuzumab.

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My exercise capacity is lower than expected for my age and sex.

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I am female.

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I am between 21 and 80 years old.

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I had surgery for early stage (I-III) breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~32 weeks

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

Treatment Details

Study Objectives

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

Primary outcome measures

peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: (C) breast cancer after completion of chemoExperimental Treatment1 Intervention

300 min/wk for 32 weeks.

Group II: (B) breast cancer after completion of chemoExperimental Treatment1 Intervention

150 min/wk for 32 weeks.

Group III: (A) breast cancer after completion of chemoExperimental Treatment1 Intervention

300 min/wk for 16 weeks, followed by 16 weeks of usual care.

Group IV: (D) breast cancer after completion of chemoActive Control1 Intervention

150 min/wk for 16 weeks, followed by 16 weeks of usual care.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,655 Previous Clinical Trials

40,933,067 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,470 Total Patients Enrolled

203 Trials studying Breast Cancer

81,137 Patients Enrolled for Breast Cancer

Jessica Scott, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

6 Previous Clinical Trials

688 Total Patients Enrolled

3 Trials studying Breast Cancer

458 Patients Enrolled for Breast Cancer

Media Library

Aerobic Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04458532 — N/A

Frequently Asked Questions

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

Are geriatric individuals being accepted as candidates for this empirical investigation?

"This particular study is exclusively recruiting patients aged between 21 and 80. However, there are 64 trials specifically tailored to minors while 2208 clinical studies exist for elderly individuals."

Answered by AI

How many individuals are partaking in this research endeavor?

"Agreed. According to clinicaltrials.gov, this medical trial is currently enrolling patients and was initially posted on October 8th 2020. 152 participants are needed from 1 location with the last edit occurring on August 24th 2022."

Answered by AI

Who would be deemed an eligible participant of this experiment?

"This medical trial is currently enrolling 152 female patients, aged 21 to 80, who have been diagnosed with breast cancer. To be considered eligible for this study they must additionally meet the following criteria: surgically resected early stage (I-III) primary breast cancer diagnosis; age ≥ 45 without a menstrual cycle in two years or more; chemically and/or surgically induced menopause through ovarian suppression as determined by their oncologist; estradiol level of ≤30 pg/mL; post surgical treatment including radiation, chemotherapy, trastuzumab and an exercise tolerance below that predicted for active individuals relative to their age"

Answered by AI

Are there any vacancies remaining in this experiment for individuals to join?

"Affirmative. Clinicaltrials.gov attests to this medical trial being actively enrolled, with the initial post-date of October 8th 2020 and a last update on August 24th 2022. The study requires 152 patients from one health facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer

2020. "Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04458532.

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