NCT02842658

Brief Summary

The purpose of this study is to determine whether a supervised exercise-training program, initiated prior to chemotherapy induction (pre-conditioning) and continued throughout chemotherapy treatment, can preserve short- and long-term cardiovascular performance, skeletal muscle function, cognitive ability and quality of life better than current standard or care recommendations for exercise during chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2019

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

3.5 years

First QC Date

April 15, 2016

Last Update Submit

February 20, 2020

Conditions

Breast Cancer

Keywords

ChemotherapyExercise

Outcome Measures

Primary Outcomes (2)

  • Change in left ventricular ejection fraction

    Echocardiography will be used to assess biventricular systolic function.

    baseline, approximately 2 months

  • Change in diastolic function

    Echocardiography will be used to assess biventricular diastolic function.

    baseline, approximately 2 months

Study Arms (2)

A high-intensity interval exercise group

ACTIVE COMPARATOR

Supervised exercise training with be carried out at the Mayo Clinic Cardiac rehabilitation center on cycle ergometers using EKG telemetry. Treatment will begin one week prior to chemotherapy and is tailored around 8 weeks.

Other: A high-intensity interval exercise group

An attention-control group

OTHER

Patients will receive counseling regarding physical activity during chemotherapy. Patients will receive a weekly phone call to maintain physical activity during chemotherapy and compliance will be verified using physical activity diaries and pedometers.

Other: An Attention-Control Group

Interventions

A high-intensity interval exercise groupOTHER

To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested

A high-intensity interval exercise group
An Attention-Control GroupOTHER

Patients will be contacted weekly to access physical activity. To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested

An attention-control group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent
  • Subjects will have been recently diagnosed with breast cancer (stage I, II or III)
  • Subjects must be scheduled by their oncologist to undergo anthracycline based chemotherapy (doxorubicin and cyclophosphamide) in the neoadjuvant/adjuvant setting

You may not qualify if:

  • Unstable angina
  • Myocardial infarction in the past 4 weeks
  • Uncompensated heart failure
  • New York Heart Association class IV symptoms
  • Complex ventricular arrhythmias
  • Medical orthopedic conditions precluding stationary cycling
  • Medical conditions precluding neuropsychological assessment
  • Symptomatic severe aortic stenosis
  • Acute pulmonary embolus
  • Acute myocarditis
  • Untreated high-risk proliferative retinopathy
  • Recent retinal hemorrhage
  • Uncontrolled hypertension
  • Sodium and/or Potassium ≥ Grade 2
  • Pregnant Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Farouk Mookadam, MBBCh

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2016

First Posted

July 25, 2016

Study Start

April 1, 2016

Primary Completion

October 18, 2019

Study Completion

October 18, 2019

Last Updated

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)