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Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

NCT ID: NCT03280836

Last Updated: 2023-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-03

Study Completion Date

2020-12-21

Brief Summary

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The investigators seek to conduct a home based exercise intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to determine whether breast cancer patients can be enrolled, randomized, retained, and comply with exercise program; and, the feasibility of acquiring, managing and analyzing clinical data.

Detailed Description

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Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that aerobic exercise training is safe during primary adjuvant therapy and improves cardiopulmonary function and patient related outcomes. Cardiopulmonary fitness is highly predictive of overall and cardiovascular specific mortality in women. Specifically, an increase in cardiopulmonary fitness of approximately 10% has been associated with a 19% reduction in risk for CV mortality. This is important as breast cancer patients already present at diagnosis with 31% lower cardiopulmonary fitness levels compared to healthy age-matched women. This enhanced risk for cardiovascular mortality in breast cancer patients is further compounded by cardiotoxic chemotherapy, which causes permanent cardiac damage. Few studies have tested the efficacy of exercise prescriptions that incorporate high intensity aerobic exercise training in cancer patients, especially those receiving chemotherapy. Therefore, the investigators seek to conduct an at home aerobic exercise training intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy

Conditions

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Breast Neoplasm Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized to the intervention or control arm.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control

We ask that participants in the control arm do not start an exercise program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise

Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.

Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.

The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.

Interventions

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Exercise

All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.

The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women with a breast cancer diagnosis (Stage I-IIIC)
* Sedentary (\< 75 min/wk of moderate intensity exercise over the past month)
* No previous history of anthracycline based chemotherapy
* Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease)
* Absence of contraindications for neoadjuvant chemotherapy
* Scheduled to receive neoadjuvant chemotherapy
* Primary attending oncologist approval

Exclusion Criteria

* Absolute contraindications for exercise stress testing

* acute myocardial infarction (3-5 days)
* unstable angina
* uncontrolled arrhythmias causing symptoms or hemodynamic compromise
* syncope
* acute endocarditis
* acute myocarditis or pericarditis
* uncontrolled heart failure
* acute pulmonary embolus or pulmonary infarction
* thrombosis of lower extremities
* suspected dissecting aneurysm
* uncontrolled asthma
* pulmonary edema
* room air desaturation at rest ≤85%
* respiratory failure
* acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
* mental impairment leading to inability to cooperate
* decisional impairment
* Non-English speaking
* Women only diagnosed with ductal carcinoma in situ
* Women diagnosed with stage 4 metastatic breast cancer
* Pregnant women
* Men
* Children
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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NRG Oncology

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen M Sturgeon, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Penn State

Locations

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Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Sturgeon KM, Smith AM, Federici EH, Kodali N, Kessler R, Wyluda E, Cream LV, Ky B, Schmitz KH. Feasibility of a tailored home-based exercise intervention during neoadjuvant chemotherapy in breast cancer patients. BMC Sports Sci Med Rehabil. 2022 Feb 25;14(1):31. doi: 10.1186/s13102-022-00420-6.

Reference Type RESULT
PMID: 35216638 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5517

Identifier Type: -

Identifier Source: org_study_id