NCT02006979

Brief Summary

In rodents, a single bout of exercise prior to injection of a chemotherapy agent used to treat breast cancer prevents or attenuates a number of markers of cardiac injury. This study will investigate whether this finding translates to human breast cancer patients. Participants scheduled to receive chemotherapy for breast cancer will be randomized to exercise or no exercise 24 hours prior to every chemotherapy treatment. The effect on cardiac function will be compared between groups noninvasively by echocardiography and electrocardiography and a venous blood draw at baseline before chemotherapy, after the first treatment and at the end of chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_1 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

First Submitted

Initial submission to the registry

December 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2016

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

October 25, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

December 5, 2013

Results QC Date

November 8, 2017

Last Update Submit

October 23, 2019

Conditions

Breast Cancer

Keywords

cardiotoxicityChemotherapy, AdjuvantBreast NeoplasmsExerciseCardiotoxinsEchocardiographySpeckle trackingBiological MarkersElectrocardiography

Outcome Measures

Primary Outcomes (1)

  • Global Longitudinal Strain

    Assessed with 2D speckle tracking echocardiography

    24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle

Secondary Outcomes (3)

  • NT-proBNP

    24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle

  • Cardiac Troponin T

    24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle

  • LV Twist

    24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle

Other Outcomes (1)

  • Patient-reported Symptoms

    <1 week before the first doxorubicin, <3 days before the 2nd, 3rd, and 4th doxorubicin, 7-14 days after completion of the last doxorubicin cycle

Study Arms (2)

Exercise

EXPERIMENTAL

an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post

Other: exercise

No exercise

NO INTERVENTION

no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines

Interventions

exerciseOTHER

An acute bout of exercise performed 24 hours prior to every anthracycline infusion.

Exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed with stage I-IIIA breast cancer
  • scheduled to receive neoadjuvant or adjuvant doxorubicin chemotherapy in cycles of 2-3 weeks long
  • receive their oncologist's approval to exercise
  • be able to complete first time point of data collection prior to first chemotherapy cycle
  • be able to understand and provide written informed consent in English

You may not qualify if:

  • concurrent participation in a structured exercise program or study
  • have orthopedic limitations to exercise
  • pre-existing cardiovascular disease
  • uncontrolled hypertension (blood pressure ≥ 140/90 mmHg)
  • uncontrolled diabetes
  • respiratory disease
  • current smoking status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia Breast Cancer Research Exercise Gym

Vancouver, British Columbia, V5Z 4C2, Canada

Location

MeSH Terms

Conditions

Breast NeoplasmsCardiotoxicityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and InjuriesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Amy Kirkham, Postdoctoral Research Fellow
Organization
University of Alberta
amy.kirkham@ualberta.ca
7804926874

Study Officials

  • Kristin L Campbell, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Kristin Campbell

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 10, 2013

Study Start

January 15, 2016

Primary Completion

May 25, 2016

Study Completion

May 25, 2016

Last Updated

October 25, 2019

Results First Posted

October 25, 2019

Record last verified: 2019-10

Locations

CA(1)