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Acute Exercise Cardioprotection From Doxorubicin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02006979
First Posted: December 10, 2013
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
Kristin Campbell, University of British Columbia
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Kristin Campbell, 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 ]

Secondary Outcome Measures:
  • NT-proBNP [ Time Frame: 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle ]
    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 ]

Enrollment: 24
Actual Study Start Date: January 15, 2016
Study Completion Date: May 25, 2016
Primary Completion Date: May 25, 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006979


Locations
Canada, British Columbia
University of British Columbia Breast Cancer Research Exercise Gym
Vancouver, British Columbia, Canada, V5Z 4C2
Sponsors and Collaborators
University of British Columbia
British Columbia Cancer Agency
Investigators
Principal Investigator: Kristin L Campbell, PhD University of British Columbia
  More Information

Responsible Party: Kristin Campbell, Dr. Kristin Campbell, University of British Columbia
ClinicalTrials.gov Identifier: NCT02006979     History of Changes
Other Study ID Numbers: H13-03090
First Submitted: December 5, 2013
First Posted: December 10, 2013
Last Update Posted: April 24, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action