Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

NCT03280836 | Completed Results DMC

• 1 other identifier: 5517
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Neoplasm; Physical Activity

Outcome Measures

Primary Outcomes (3)

• Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.

  Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.

  4 weeks

• Participant Adherence to the Exercise Intervention

  Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor.

  Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion)

• Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection

  Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline.

  Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline)

Study Arms (2)

Control

NO INTERVENTION

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

Exercise

EXPERIMENTAL

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.

Behavioral: Exercise

Interventions

Exercise 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.

Exercise

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• NRG Oncology: collaborator

Study Sites (2)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 35216638 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The study was closed to recruitment at n=19, 1 patient short of anticipated enrollment (n=20) due to the COVID-19 pandemic.

Results Point of Contact

• Title: Dr. Kathleen Sturgeon
• Organization: Penn State University

kms99@psu.edu

7175314530

Study Officials

• Kathleen M Sturgeon, PhD

  Assistant Professor, Penn State

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to the intervention or control arm.

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 13, 2017
• Study Start: August 3, 2017
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: December 5, 2023
• Results First Posted: May 31, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)