Acute Exercise Cardioprotection From Doxorubicin

This study is not yet open for participant recruitment.
Verified December 2013 by University of British Columbia
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02006979
First received: December 5, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Other: exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Exercise Before Doxorubicin Chemotherapy on Cardiac Function

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • global longitudinal strain [ Time Frame: 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NT-proBNP [ Time Frame: 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle ] [ Designated as safety issue: No ]
    biomarker of cardiac injury

  • signal-averaged ECG area ratio [ Time Frame: 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
an acute bout of exercise performed ≤24 hours prior to each cycle
 of anthracyclines and no exercise for 48 hours post
Other: exercise
An acute bout of exercise performed 24 hours prior to every anthracycline infusion.
No Intervention: No exercise
no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • concurrently enrolment in an exercise study
  • have orthopedic limitations to exercise
  • pre-existing cardiovascular disease
  • uncontrolled hypertension (blood pressure ≥ 140/90 mmHg)
  • uncontrolled diabetes
  • respiratory disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02006979

Locations
Canada, British Columbia
University of British Columbia Breast Cancer Research Exercise Gym Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4C2
Contact: Kristin L Campbell, PhD    (604) 872-4527    kristin.campbell@ubc.ca   
Principal Investigator: Kristin L Campbell, PhD         
Sponsors and Collaborators
University of British Columbia
British Columbia Cancer Agency
Investigators
Principal Investigator: Kristin L Campbell, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02006979     History of Changes
Other Study ID Numbers: H13-03090
Study First Received: December 5, 2013
Last Updated: December 12, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
cardiotoxicity
Chemotherapy, Adjuvant
Breast Neoplasms
Exercise
Cardiotoxins
Echocardiography
Speckle tracking
Biological Markers
Electrocardiography

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014